Computed Tomography Laser Mammography (CTLM)

Computed Tomography Laser Mammography (CTLM) is a relatively new and very promising field of optical imaging. In combination with conventional mammography and other techniques, it has the power to provide detailed information of breast abnormalities. It provides unique images of blood flow to the breast, allowing detection of any new blood vessels in the breast which is a hallmark of developing tumors. This information on angiogenesis in the breast tissue can help physicians differentiate between benign and malignant tumors, thereby giving them more information for a proper diagnosis [2].

Fig. 2a: The Computed Tomography Laser Mammography (CTLM) Model 1020. Image taken from: www.imds.com

Optical Imaging: A Powerful Complement to Mammography and Ultrasound in Breast Cancer Diagnosis

Optical imaging has emerged as a valuable adjunct to traditional breast cancer diagnostic methods like mammography and ultrasound. While mammography and ultrasound focus primarily on the structural aspects of breast tissue—such as detecting masses or calcifications—optical imaging provides additional functional insights that conventional methods may miss. By analyzing tissue composition, blood flow, and oxygenation levels, optical imaging offers a deeper and more dynamic view of the tissue’s physiological state, which can be crucial for early detection and accurate diagnosis.

“Optical imaging goes beyond the structural details, offering functional data that can enhance the early detection and diagnosis of breast cancer.”

How Optical Imaging Works in Breast Cancer Diagnostics

Optical imaging in breast cancer diagnostics typically employs near-infrared (NIR) light, with wavelengths ranging from 600 to 1000 nm. NIR light is particularly well-suited for this application because it penetrates several centimeters into breast tissue, allowing for the examination of deeper structures without requiring invasive procedures. This depth of penetration is critical for identifying abnormalities that may not be visible on standard mammograms or ultrasounds.

The Process of Optical Imaging

The process involves transmitting NIR light through the breast tissue. As the light interacts with the tissue, it is absorbed and scattered in various ways, depending on the tissue’s composition, density, and biochemical properties. Different tissue types—including healthy tissue, fat, blood vessels, and potential cancerous areas—have distinct absorption and scattering patterns. These differences allow for a nuanced analysis of the tissue’s condition, providing functional data that complements the structural information gathered by mammography or ultrasound.

• NIR Light Penetration: The near-infrared light used in optical imaging penetrates deep into the breast tissue, reaching several centimeters beneath the surface.
• Tissue Interaction: As the light passes through, it is absorbed and scattered based on the tissue’s properties, allowing for the differentiation between healthy tissue and potential malignancies.
• Functional Data: Optical imaging provides information about blood flow, oxygenation levels, and tissue composition, offering a more comprehensive view of the breast’s physiological state.

The Advantages of Optical Imaging in Breast Cancer Diagnosis

There are several distinct advantages to incorporating optical imaging into breast cancer diagnostics:

• Non-Invasive: Optical imaging is a non-invasive technique that doesn’t require radiation exposure or contrast agents, making it a safer option for patients, particularly for repeated imaging.
• Complementary Data: This method provides functional insights that complement the structural data from mammography and ultrasound, offering a more holistic view of the tissue’s health.
• Improved Early Detection: By analyzing blood flow and oxygenation, optical imaging can help detect early-stage cancer, improving the chances of successful treatment.

Conclusion: Enhancing Breast Cancer Diagnostics

As breast cancer diagnostics continue to evolve, optical imaging stands out as a powerful complement to traditional methods. Its ability to provide functional data—such as tissue composition, blood flow, and oxygenation levels—gives clinicians a more comprehensive understanding of the breast tissue’s physiological state. By integrating optical imaging with conventional techniques like mammography and ultrasound, healthcare providers can achieve earlier detection, more accurate diagnoses, and improved patient outcomes.

How Optical Imaging Enhances Breast Cancer Diagnosis

The system’s detectors play a crucial role in capturing the unabsorbed light that passes through the breast tissue during optical imaging. This residual light carries valuable information about the tissue it interacted with, and advanced computer algorithms are used to reconstruct detailed images from the collected data. These reconstructed images go beyond showing structural changes; they reveal functional insights by mapping areas where the absorption and scattering of light suggest changes in blood flow, oxygenation, or cellular composition.

“Optical imaging doesn’t just show what’s there—it helps understand how the tissue is functioning, offering critical information about blood flow and oxygenation that structural imaging may miss.”

Detecting Functional Abnormalities

One of the most powerful aspects of optical imaging is its ability to detect functional abnormalities in breast tissue. For instance, cancerous tissues often display irregular blood flow or increased angiogenesis (the formation of new blood vessels). These functional changes can be visualized through optical imaging, providing additional clues that structural imaging alone might not detect.

• Irregular Blood Flow: Cancerous tissues tend to show abnormal blood vessel growth and patterns, which optical imaging can detect through differences in light absorption.
• Oxygenation Levels: Optical imaging can map oxygenation changes within tissues, which is especially useful for identifying malignant growths.

Complementing Structural Imaging

While traditional imaging methods, such as mammograms, can reveal the presence of a mass, they often fall short in providing detailed information about the nature of that mass. Optical imaging adds another layer of diagnostic value by examining functional aspects like blood flow and oxygenation levels. This added data improves diagnostic accuracy, particularly in cases where traditional imaging methods may be inconclusive, such as with dense breast tissue.

For example, in dense breast tissue, where a mammogram might struggle to identify a tumor, optical imaging can provide functional data that helps differentiate between benign and malignant masses. This integration of both structural and functional data allows physicians to make more accurate diagnoses and create more tailored treatment plans for each patient.

CTLM: A Breakthrough in Optical Imaging Technology

One of the most advanced systems utilizing optical imaging for breast cancer diagnosis is the Computed Tomography Laser Mammography (CTLM) device, developed by Imaging Diagnostic Systems, Inc. The CTLM system represents a significant leap forward in breast cancer screening, offering a non-invasive, painless alternative to conventional methods such as mammography.

Advantages of the CTLM System

• Non-Invasive: Unlike traditional mammograms, which often require uncomfortable compression of the breast tissue, the CTLM system eliminates the need for compression, making the procedure more comfortable for patients.
• No Radiation Exposure: The CTLM system does not expose patients to ionizing radiation, reducing the potential health risks associated with conventional imaging methods.
• Patient-Friendly: With no discomfort or health risks involved, the CTLM system is particularly beneficial for women who may find traditional mammography unsuitable or uncomfortable.

Conclusion: Enhancing Diagnostic Accuracy with Optical Imaging

By offering functional insights that complement traditional structural imaging techniques, optical imaging improves the overall accuracy of breast cancer diagnosis. Devices like the CTLM system provide a safer, non-invasive alternative to conventional imaging methods, offering patients a more comfortable experience without compromising diagnostic precision. The integration of both structural and functional data gives physicians a more comprehensive understanding of breast tissue health, allowing for more accurate diagnoses and personalized treatment plans.

The CTLM System: Mapping Blood Flow for Breast Cancer Detection

The Computed Tomography Laser Mammography (CTLM) system operates by creating a detailed 3D map of blood flow within the breast tissue. This approach is crucial in identifying malignant tumors, which often exhibit increased angiogenesis—the formation of new blood vessels to supply the growing cancerous tissue. By mapping these blood flow patterns and identifying areas with higher vascular activity, CTLM can detect potential malignancies based on the physiological changes in the tissue, rather than relying solely on structural abnormalities.

How Blood Flow Mapping Enhances Cancer Detection

“CTLM focuses on the physiological changes in breast tissue, such as increased blood vessel formation, which are often early indicators of malignancy.”

• Angiogenesis as a Marker: Cancerous tissues stimulate the formation of new blood vessels to meet their metabolic demands. CTLM highlights these areas of increased vascular activity, which can signal the presence of a tumor even before it becomes visible on traditional scans.
• Functional Imaging Advantage: Unlike traditional imaging methods, which rely on detecting structural changes (like masses or calcifications), CTLM offers a deeper, functional perspective by identifying physiological changes such as increased blood flow, which can precede visible structural abnormalities.

Complementing Other Imaging Techniques

One of the standout features of CTLM is its ability to enhance and complement other breast cancer diagnostic tools. The system is highly flexible and can be integrated with several other imaging modalities, including:

• Mammography
• Ultrasound
• MRI
• Positron Emission Tomography (PET)

By combining the functional imaging from CTLM with the structural insights provided by these traditional methods, clinicians gain a more comprehensive understanding of breast health. This multimodal approach significantly improves diagnostic sensitivity and specificity, helping to determine whether abnormalities are benign or malignant.

Example: CTLM in Practice

For example, a suspicious mass detected on a mammogram or ultrasound might require further evaluation. CTLM can offer additional information about the blood flow surrounding the mass, providing critical insight into whether the mass is likely malignant. Similarly, when paired with MRI or PET scans, CTLM can non-invasively monitor changes in blood vessels over time, helping physicians assess tumor growth or the effectiveness of treatments. This combination of techniques leads to a more accurate and nuanced diagnosis.

Improving Diagnostic Accuracy and Early Detection

The integration of CTLM into breast cancer diagnostics provides several key benefits, including:

• Enhanced Sensitivity: By focusing on blood flow changes rather than solely structural abnormalities, CTLM increases the sensitivity of cancer detection, identifying tumors that may not yet be visible on other imaging scans.
• Comprehensive Diagnostics: CTLM complements other imaging techniques, offering a fuller picture of the breast’s physiological and structural health, which is especially valuable in complex cases.
• Non-Invasive Monitoring: CTLM offers a non-invasive way to track changes in tumor blood vessels over time, helping assess both the progression of cancer and the effectiveness of treatments without the need for repeated invasive procedures.

Conclusion: CTLM as an Invaluable Tool in Breast Cancer Management

In summary, CTLM enhances the accuracy of breast cancer detection by providing critical functional information that other imaging techniques may miss. Its ability to map blood flow and angiogenesis allows for earlier detection of malignancies, even before visible structural changes occur. By integrating CTLM with other modalities like mammography, ultrasound, and MRI, clinicians can make more informed, accurate diagnoses, improving the chances of early detection and effective treatment. As a non-invasive, highly flexible imaging tool, CTLM is poised to play a key role in the future of breast cancer diagnostics.

CTLM System: Gaining International Recognition and Certifications

The Computed Tomography Laser Mammography (CTLM) system has earned widespread international recognition, securing multiple key certifications and regulatory approvals that underscore its safety, effectiveness, and potential as a leading tool in breast cancer diagnostics.

Global Certifications and Approvals

“CTLM’s certifications affirm its global credibility as a safe and effective diagnostic tool in breast cancer imaging.”

• European CE Marking: Certifies the CTLM system’s compliance with health, safety, and environmental protection standards across the European Union.
• Health Canada Approval: Allows for the system’s use in Canadian healthcare facilities, expanding its reach into North American medical markets.
• China SFDA Approval: Secures the system’s position in China’s extensive healthcare market, validating its effectiveness in one of the world’s largest medical regions.

These international approvals demonstrate the CTLM system’s credibility and growing global reach, solidifying its role in breast cancer diagnostics across multiple healthcare systems.

Compliance with International Safety Standards

The CTLM system complies with rigorous international quality and safety standards:

• UL Certification: Ensures compliance with Underwriters Laboratories’ strict electrical safety standards.
• ISO 13485:2003 Certification: A globally recognized standard for quality management systems specific to medical devices.
• FDA Export Certification: Authorizes the system’s distribution to countries outside of the United States, further expanding its global presence.

These certifications reinforce the CTLM system’s reliability, demonstrating that it meets the highest quality and safety standards required in the medical imaging industry.

Pending Approvals in Additional Markets

While the CTLM system has secured numerous international certifications, it is still awaiting marketing approvals in a few regions:

• Mexico (COFEPRIS): Pending approval in Mexico’s regulatory system for healthcare products.
• Russia (GOST-R): Awaiting clearance from Russia’s GOST-R certification, which focuses on compliance with national standards.

Despite these pending clearances, the system’s widespread adoption in major global healthcare markets highlights its effectiveness and potential to become a critical part of breast cancer diagnostics worldwide.

CTLM: Enhancing Multi-Modal Breast Cancer Diagnostics

The CTLM system is designed to provide functional imaging that complements traditional structural imaging techniques, making it an invaluable tool in breast cancer diagnostics. When used in combination with other diagnostic modalities such as mammography, ultrasound, MRI, and PET, CTLM offers a comprehensive view of breast health by combining both functional and structural data. This multi-modal approach enhances diagnostic accuracy, enabling clinicians to make more informed and personalized treatment decisions.

Benefits of Multi-Modal Imaging

• Non-Invasive, Radiation-Free: CTLM provides a non-invasive imaging option that does not involve exposure to ionizing radiation, improving patient safety.
• Integration with Traditional Imaging: By combining functional and structural imaging, CTLM enhances diagnostic sensitivity and specificity, improving the overall accuracy of breast cancer diagnoses.

Meeting Global Demand for Advanced Breast Cancer Diagnostics

As the demand for innovative and effective cancer diagnostic tools continues to rise worldwide, the CTLM system stands out as a promising solution. Its ability to integrate seamlessly with other imaging tools and provide non-invasive, functional insights makes it a key player in improving breast cancer detection and care. By advancing the accuracy and efficiency of diagnostics, CTLM has the potential to make a significant impact across diverse healthcare systems globally.

“CTLM: a non-invasive, radiation-free solution offering new perspectives in breast cancer detection.”

CTLM® System: A Game-Changer for Dense Breast Tissue Imaging

Linda Grable, CEO of Imaging Diagnostic Systems, Inc., emphasizes the transformative impact of the CTLM® system, particularly in overcoming the long-standing challenge of imaging dense breast tissue—a known obstacle in breast cancer diagnostics. According to Grable,

“The capability of CTLM® is found to be less impeded by dense breast tissue than mammography and will eventually provide radiologists with a complementary, non-radiation-based imaging tool, particularly for patients with dense breast tissue.”

Challenges of Dense Breast Tissue in Mammography

This statement marks a significant shift in breast imaging. Dense breast tissue can obscure abnormalities in mammograms, reducing their effectiveness in detecting early-stage cancers. The CTLM® system, by contrast, utilizes near-infrared (NIR) light to penetrate dense tissue more effectively. This technology offers a clearer view of blood flow and vascular structures without being hindered by tissue density, allowing for better detection of abnormalities.

Patient-Centered Benefits of the CTLM® System

• No Radiation Exposure: Unlike traditional imaging methods, CTLM® eliminates the need for radiation exposure, addressing concerns for women undergoing repeated breast cancer screenings.
• Pain-Free Experience: CTLM® does not require the uncomfortable compression of breast tissue, making it a more tolerable and painless procedure compared to mammography.
• No Contrast Agents: Unlike MRI, CTLM® does not rely on injected contrast agents, reducing the risk of adverse reactions, especially for patients with kidney issues or allergies.

By offering a painless, non-invasive alternative without the use of radiation or contrast agents, CTLM® overcomes many of the barriers that deter women from regular breast cancer screenings. These patient-centered benefits make it a more appealing option for both healthcare providers and patients.

Global Impact and Accessibility

Grable’s vision for CTLM® extends beyond improved imaging for women with dense breast tissue. She envisions CTLM® as a global solution for enhancing breast cancer detection. Dense breast tissue affects a significant portion of women worldwide—studies show that around 40-50% of women have dense breasts. This can make cancer detection challenging when relying solely on standard mammography. CTLM® has the potential to improve breast cancer diagnostics globally, offering a more accurate and accessible tool for diverse populations.

The earlier and more accurate identification of malignancies could significantly improve patient outcomes and reduce breast cancer mortality rates, especially in regions where access to advanced imaging technology is limited. As global demand for effective diagnostic tools rises, CTLM® stands out as a promising option for enhancing cancer detection across different healthcare systems.

Integration with Other Imaging Modalities

Another key advantage of the CTLM® system is its flexibility in integrating with other diagnostic tools such as:

• Mammography
• Ultrasound
• MRI
• PET Scans

This multi-modal approach enhances diagnostic accuracy by combining the functional imaging capabilities of CTLM® with the structural insights provided by these other modalities. Grable notes that the future of breast cancer diagnostics will rely on developing complementary technologies that work together, providing a comprehensive understanding of breast health.

Improved Diagnostic Sensitivity

“Mammography alone has a sensitivity rate of only 34.4% for detecting abnormalities, particularly in dense breast tissue. When combined with CTLM®, this rate increases dramatically to 81.57%.”

Studies evaluating the efficacy of the CTLM® system show a substantial improvement in diagnostic sensitivity when used alongside mammography. This more than doubling of detection rates is a significant advancement, providing a critical advantage in identifying potential malignancies, especially in women with dense breast tissue where traditional imaging often falls short.

Conclusion: A New Era in Breast Cancer Diagnostics

The CTLM® system represents a groundbreaking advancement in breast cancer imaging. By offering a non-invasive, radiation-free, and more accurate tool for diagnosing breast abnormalities—particularly in women with dense breast tissue—it has the potential to improve diagnostic outcomes on a global scale. With its ability to integrate seamlessly with existing imaging modalities, CTLM® is poised to become a vital component of comprehensive breast cancer diagnostics, offering earlier detection and more personalized care for patients worldwide.

CTLM®: Transforming Breast Cancer Detection in Women with Dense Breast Tissue

This improvement is particularly noteworthy for the 40-50% of women globally who have mammographically dense breasts. Dense breast tissue can obscure tumors on mammograms, making early-stage cancers more difficult to detect. The increased sensitivity of CTLM® stems from its ability to capture functional data related to blood flow and angiogenesis rather than relying solely on structural abnormalities.

Key Advantage: Detecting Tumor-Induced Angiogenesis

• Angiogenesis Detection: Tumors often induce the formation of new blood vessels to support their rapid growth. The CTLM® system excels at identifying these areas of increased vascular activity, which can go unnoticed on mammograms alone.
• Blood Flow Patterns: By detecting changes in blood flow patterns and vascular density, CTLM® significantly enhances the ability to spot potential abnormalities, particularly in dense breast tissue.

“By identifying areas of abnormal blood flow and angiogenesis, CTLM® enhances the likelihood of spotting tumors that may be missed by traditional mammograms.”

CTLM® and Early Detection: A Critical Breakthrough

The integration of CTLM® into breast cancer screening protocols could transform early detection efforts, particularly for populations with dense breast tissue. Early detection is critical because cancers found at an early stage are generally more treatable and have a better prognosis. Early detection through enhanced imaging is key to improving breast cancer survival rates. CTLM® complements mammography by providing functional data about blood flow patterns, adding a new layer of diagnostic accuracy. This allows physicians to make more informed decisions about further testing or intervention.

Broader Applications in Breast Cancer Diagnostics

Beyond dense breast tissue, CTLM® has broader implications for breast cancer diagnostics. Its non-invasive, radiation-free nature makes it ideal for repeated imaging, particularly for women at higher risk of breast cancer who require regular monitoring. Traditional imaging methods expose patients to ionizing radiation, raising concerns for those needing frequent screenings. The radiation-free CTLM® system addresses this issue, offering a safer alternative.

• Non-Invasive: CTLM® eliminates the need for invasive biopsies in many cases by providing clear functional data about suspicious areas.
• Radiation-Free: Ideal for women requiring regular screenings, CTLM® poses no risk of radiation exposure.

As research continues to validate its efficacy, CTLM® is poised to become an essential tool in breast cancer screening. It offers more precise imaging in challenging cases, potentially reducing the number of false negatives associated with dense breast tissue, where traditional methods often fall short.

CTLM®: A Game-Changer in Breast Cancer Detection

The significant increase in sensitivity demonstrated by CTLM® highlights its potential as a game-changer in breast cancer detection. For healthcare providers seeking accurate, patient-friendly diagnostic tools, CTLM® stands out as a promising solution that could revolutionize breast cancer detection and management, particularly for women facing challenges with traditional imaging methods.

Understanding Diffuse Optical Tomography (DOT) Technology

The CTLM® system employs Diffuse Optical Tomography (DOT), an advanced 3D laser imaging technique that creates detailed digital volumetric models of the breast. This method is particularly useful for capturing functional data related to blood flow and tissue composition, offering insights that go beyond structural images provided by traditional mammography or ultrasound. DOT technology generates a comprehensive 3D representation of the breast, helping physicians detect and assess abnormalities with greater precision.

The CTLM® Procedure: A Comfortable Patient Experience

• Comfortable Positioning: During the procedure, the patient lies face-down on a specially designed scanning bed, allowing one breast to be naturally suspended in a circular aperture within the scanning chamber.
• No Compression Required: Unlike mammograms, CTLM® does not require uncomfortable breast compression, making the experience less painful and more tolerable.
• Uniform Laser Exposure: The circular aperture ensures the breast is uniformly exposed to the scanning laser, which is key to producing consistent and accurate images.

This method not only provides stable positioning but also ensures optimal imaging conditions. Patients benefit from a more comfortable procedure without compromising image quality.

Conclusion: Advancing Breast Cancer Detection

The CTLM® system’s ability to offer functional imaging through DOT technology, combined with its non-invasive nature, makes it an innovative tool in breast cancer diagnostics. With its potential to improve early detection, especially in women with dense breast tissue, CTLM® is set to revolutionize breast cancer screening. By integrating with traditional imaging methods, CTLM® offers a more comprehensive, patient-friendly approach to breast health, leading to better outcomes through more accurate diagnoses and early intervention.

CTLM® System: How it Works

The CTLM® system utilizes a 360-degree rotating laser beam to capture data from multiple angles, providing comprehensive breast imaging. This process is similar to a traditional CT scan, but with one key difference—CTLM® uses near-infrared (NIR) light rather than ionizing radiation. NIR light is absorbed differently by healthy tissues and areas with increased vascularization, such as tumors, making it particularly useful for identifying abnormalities. The use of NIR also enables deeper penetration into breast tissue, making CTLM® an excellent choice for imaging patients with dense or heterogeneous breast tissue, where conventional mammography may struggle.

Key Advantages of the CTLM® System

• Non-Invasive Imaging: The laser-based technology eliminates the need for compression and radiation, providing a safer and more comfortable experience for patients.
• Deeper Tissue Penetration: NIR light penetrates deeper into dense breast tissue, offering detailed imaging where mammography might fall short.
• Functional Data: By detecting vascularization and blood flow patterns, CTLM® can identify areas of concern, such as tumors, based on increased hemoglobin concentration.

How the Imaging Process Works

As the laser beam rotates around the breast, it captures absorption data from multiple cross-sectional slices. This process is akin to a CT scan, but instead of radiation, CTLM® relies on the safe use of NIR light. The light is absorbed by tissues at different rates depending on their composition. For example, tumors often exhibit abnormal vascularization, which results in increased absorption of light due to the presence of new blood vessels. The detectors within the CTLM® system then collect this data to provide insights into tissue health and structure.

Step-by-Step Process:

• The laser beam rotates 360 degrees around the breast, capturing absorption data from multiple angles.
• Detectors collect absorption data from cross-sectional slices of breast tissue.
• Advanced algorithms process the data to reconstruct individual cross-sections into a 3D volumetric model of the breast.
• Radiologists can view each cross-section individually or analyze the entire 3D model for a comprehensive assessment.

Building a 3D Volumetric Model for Better Diagnostics

Once the absorption data is collected, it is processed by advanced algorithms that reconstruct individual cross-sections into a 3D volumetric model of the breast. This provides physicians with detailed maps of blood flow and angiogenesis, both of which are key indicators of potential malignancies. Areas with increased hemoglobin concentration, which suggest abnormal blood vessel formation, can be easily identified within the 3D model. These features are critical for the early detection of tumors.

“By mapping blood flow and identifying increased hemoglobin concentration, CTLM® provides critical insights that aid in the early detection of breast cancer.”

Key Benefits of 3D Imaging:

• Multiple Viewing Angles: The ability to view breast tissue from multiple angles gives radiologists a clearer understanding of any abnormalities.
• Real-Time Analysis: The system allows for real-time imaging, helping radiologists make more informed decisions during the diagnostic process.
• Non-Invasive and Radiation-Free: CTLM® offers a safer, more patient-friendly option for routine screening, particularly for those at higher risk of breast cancer or those requiring frequent follow-up imaging.

Functional and Structural Insights Combined

The combination of functional data from CTLM® and structural insights from other imaging techniques like mammography and ultrasound provides a more comprehensive view of breast health. While traditional 2D imaging methods may reveal a suspicious mass, they often cannot determine whether it is benign or malignant. By adding functional information about blood flow and angiogenesis, CTLM® gives physicians the tools to make more accurate diagnoses and create personalized treatment plans.

Why CTLM® Outperforms Traditional Methods:

• Early Detection of Tumors: CTLM® excels at identifying tumors in their early stages by focusing on physiological changes such as increased vascularization.
• Dense Breast Tissue: CTLM® is particularly effective in patients with dense breast tissue, offering clearer insights than mammography alone.
• Reduced Need for Biopsies: By providing more detailed imaging, CTLM® can help reduce unnecessary biopsies, improving patient care and reducing healthcare costs.

Conclusion: A Major Leap in Breast Cancer Diagnostics

The CTLM® system’s use of Diffuse Optical Tomography (DOT) technology is a powerful tool in breast cancer diagnostics. Its ability to generate detailed, functional 3D images of the breast while avoiding the discomfort and risks associated with traditional imaging methods offers a significant advancement in both patient care and diagnostic accuracy. By integrating functional and structural data, CTLM® helps radiologists provide more precise diagnoses, particularly in challenging cases such as dense breast tissue. As CTLM® continues to gain recognition, it is poised to become an essential part of early breast cancer detection and personalized treatment strategies.

 

Fig. 2b: Breast optical imaging prototype. Patient lies in prone position. Soft compression in a plane and detection in the opposite one [5].

 

CTLM® System: Optimizing Breast Imaging with 808 nm Laser Technology

The CTLM® system stands out for its use of a laser beam with a wavelength of 808 nm, which is particularly effective for imaging breast tissue. This wavelength aligns perfectly with the absorption characteristics of hemoglobin, the oxygen-carrying molecule in red blood cells. Both oxygenated (oxyhemoglobin) and deoxygenated blood (deoxyhemoglobin) absorb light efficiently at 808 nm. This allows the system to capture highly detailed images of areas with increased blood flow or vascularization, a key indicator in the detection of tumors.

Advantages of the 808 nm Wavelength

• Targeted Imaging: Hemoglobin’s strong absorption of light at 808 nm enables the CTLM® system to focus specifically on blood-rich areas, highlighting regions with abnormal blood vessel growth, such as those found in tumors.
• Selective Absorption: While hemoglobin absorbs light strongly at this wavelength, other breast tissue components like water, fat, and skin have much weaker absorption. This differential absorption allows the system to produce clearer, more accurate images.
• Penetration of Dense Tissue: The 808 nm wavelength penetrates deeply into breast tissue, including dense tissue, which is often challenging for traditional imaging methods like mammography.

“The ability of the CTLM® system to penetrate dense breast tissue using near-infrared light at 808 nm ensures that women with dense breasts receive accurate imaging, reducing the chances of missed diagnoses.” – American Cancer Society

Why 808 nm is Ideal for Tumor Detection

The laser’s wavelength at 808 nm is optimal for detecting tumors due to its ability to identify areas of increased blood flow and vascularization, critical signs of angiogenesis. Tumors often develop an irregular network of blood vessels to supply their rapid growth, making vascular imaging essential for early cancer detection. The CTLM® system excels in visualizing these blood vessel formations, offering a functional perspective that goes beyond structural imaging provided by traditional methods like mammography or ultrasound.

Key Benefits for Tumor Detection:

• Early Detection of Abnormal Blood Flow: The system identifies changes in blood flow, which may indicate malignancies before they cause visible structural changes.
• Increased Vascular Activity: Tumors need more oxygen and nutrients to grow, resulting in more blood vessels. The CTLM® system highlights these areas, providing critical diagnostic information.

Enhanced Imaging for Dense Breast Tissue

One of the most significant advantages of the CTLM® system is its ability to penetrate and provide high-quality images of dense breast tissue. Dense breast tissue can obscure tumors on mammograms, making it more difficult to detect early-stage cancers. The CTLM® system, however, uses near-infrared light that can penetrate deeply without being hindered by dense tissue. This capability ensures accurate imaging regardless of breast density, making it an invaluable tool for women who face reduced sensitivity in mammographic screenings.

Why Dense Breast Tissue Matters:

• Challenges of Mammography: Dense breast tissue can obscure small tumors, leading to false negatives in traditional imaging methods.
• CTLM® Solution: The near-infrared light at 808 nm penetrates dense tissue, offering clearer and more precise imaging for women with dense breasts.

Functional Insights into Blood Flow and Vascular Structures

In addition to its ability to image dense tissue, the CTLM® system provides a detailed view of blood flow and vascular structures within the breast. Tumors often have an irregular and increased network of blood vessels to support their growth. By focusing on functional aspects like blood flow and vascular concentration, CTLM® enhances the detection of potential malignancies even before they cause structural changes visible on traditional imaging.

Key Functional Advantages:

• Mapping Vascular Structures: The system generates detailed images of blood vessels, offering insights into tumor growth patterns.
• Detecting Malignancies Early: By identifying areas with abnormal blood vessel growth, the CTLM® system can detect cancers at an earlier stage.

Conclusion: A Breakthrough in Breast Imaging

The use of 808 nm laser light in the CTLM® system represents a significant breakthrough in breast imaging. Its ability to precisely visualize blood flow and vascular structures, while penetrating even the densest breast tissue, enhances the early detection of breast cancer. By focusing on hemoglobin absorption and minimizing interference from other tissue components, the CTLM® system provides a clear, functional view of breast health. This makes it a crucial tool for women with dense breast tissue, where traditional imaging methods like mammography often fall short.

Learn more about how opto-acoustic technology is transforming breast cancer detection.

The CTLM’s ability to detect regions of high hemoglobin concentration plays a pivotal role in identifying areas with rich blood vessel networks, which are closely associated with tumor growth. Tumors typically stimulate a process called angiogenesis, wherein new blood vessels form to meet the tumor’s increased demand for oxygen and nutrients, facilitating rapid growth. CTLM focuses on visualizing these areas of heightened blood vessel formation, providing a functional imaging perspective that highlights regions of angiogenesis, often larger and more pronounced than the actual tumor itself.

This capacity to image angiogenesis is a significant diagnostic advancement. Angiogenesis typically extends beyond the boundaries of the tumor, meaning that the blood vessel network associated with a tumor can be detected even when the tumor remains small and less structurally obvious. For example, while a mammogram might struggle to identify tiny tumors, particularly in dense breast tissue, CTLM can reveal areas of abnormal blood vessel growth that suggest the presence of cancer. This makes CTLM an especially powerful tool for early-stage cancer detection, where tumors are often too small or subtle to be captured by conventional imaging methods.

By focusing on the vascular characteristics of tumors rather than solely relying on structural changes, CTLM offers a more comprehensive diagnostic approach. Blood vessels surrounding tumors often display irregular patterns and increased density, which are key indicators of malignancy. CTLM’s ability to visualize these vascular abnormalities enhances diagnostic sensitivity, allowing clinicians to detect tumors that might otherwise go unnoticed with traditional imaging techniques. This is particularly important for women with dense breast tissue, where structural imaging methods like mammography often have reduced sensitivity, making it harder to detect tumors at an early stage.

Moreover, because the areas of angiogenesis are typically larger than the actual tumor, CTLM allows for the detection of tumors that are not yet large enough to cause structural changes in the breast tissue. This capability is critical in the early detection of breast cancer, as identifying tumors at an early stage significantly improves treatment outcomes and survival rates. By visualizing the functional aspect of tumor growth—its vascular network—CTLM provides a more detailed and accurate picture of tumor development, offering a complementary tool to traditional imaging modalities such as mammography and ultrasound.

In sum, CTLM’s focus on imaging angiogenesis represents a key breakthrough in breast cancer diagnostics. By detecting the vascular patterns associated with tumor growth, the system enhances both the sensitivity and specificity of breast cancer detection, providing a crucial diagnostic tool, especially for early-stage cancers that may be missed by conventional imaging techniques. Its ability to highlight functional changes within the breast tissue positions CTLM as an indispensable part of a multi-modal approach to breast cancer screening and diagnosis.

Furthermore, CTLM’s non-invasive and radiation-free design, coupled with its capacity to effectively image dense and heterogeneous breast tissue, makes it a highly valuable diagnostic tool in modern radiology. Unlike traditional imaging methods such as mammography, which involve ionizing radiation and the uncomfortable compression of breast tissue, CTLM offers a safer and more patient-friendly alternative. This is particularly important for women who require frequent screenings or those with dense breast tissue, where the accuracy of conventional imaging methods is often compromised. The absence of radiation exposure also means that CTLM can be used more frequently, providing a reliable option for ongoing monitoring without increasing the patient’s risk.

One of the most significant advantages of CTLM lies in its focus on functional imaging, specifically by measuring hemoglobin absorption. By capturing detailed information on how hemoglobin behaves within the breast tissue, CTLM provides clinicians with critical insights into the blood supply feeding a tumor, which is a key indicator of its activity and aggressiveness. Tumors often exhibit abnormal blood flow patterns due to angiogenesis, and CTLM excels at detecting these vascular changes, offering a functional perspective that goes beyond merely identifying the physical presence of a tumor.

This functional imaging capability allows clinicians not only to detect tumors but also to understand their growth patterns and vascularization, providing a more nuanced view of the disease’s progression. Unlike structural imaging techniques that focus on anatomical changes, CTLM gives insights into the tumor’s biology—specifically, how it is being nourished by blood vessels. This information is crucial for determining the stage of the tumor, its potential aggressiveness, and its likelihood of spreading. For example, a tumor with a rich and irregular blood supply may be more aggressive and at a later stage of development than one with more normal blood flow.

In addition to aiding in diagnosis, CTLM’s ability to visualize the tumor’s blood supply can also guide treatment decisions. Understanding the vascular structure of a tumor can help in planning surgeries, targeting areas for biopsy, or assessing the effectiveness of treatments such as chemotherapy or anti-angiogenic therapies, which specifically aim to disrupt the tumor’s blood supply. By providing a more comprehensive view of the tumor’s functional characteristics, CTLM complements other imaging modalities and enhances the overall understanding of a patient’s disease.

Overall, the combination of CTLM’s non-invasive nature, lack of radiation, and its ability to image even the most challenging breast tissue types makes it a critical addition to the suite of diagnostic tools available to radiologists. Its focus on functional imaging through hemoglobin absorption provides clinicians with deeper insights into the biology of breast cancer, enabling more accurate diagnoses, better monitoring of disease progression, and more personalized treatment planning.

Fig. 3: The absorption spectra of the major chromophores in skin. Oxy- and deoxyhemoglobin (OxyHb and DeoxyHb) absorb equally well at 808nm, the wavelength used in CTLM scans [6].

Another important application of CTLM is in the evaluation of breast tissue after neoadjuvant therapy, a treatment administered before surgery to shrink tumors in patients with locally advanced breast cancer. Neoadjuvant therapy aims to reduce the tumor size, making surgery less invasive and improving the chances of complete tumor removal. However, one of the challenges after neoadjuvant therapy is determining whether all cancerous tissue has been eliminated or if residual disease remains. This is where CTLM has demonstrated significant promise, particularly in its ability to detect residual angiogenesis—new blood vessel formation that tumors rely on for growth.

CTLM excels in identifying regions of residual angiogenesis, which can be more challenging to detect with conventional imaging methods like MRI. Tumors often leave behind microscopic pockets of abnormal vascular activity, even when the tumor itself appears to have shrunk significantly. Since CTLM focuses on the functional imaging of blood flow and hemoglobin absorption, it can highlight areas of increased vascularization that might suggest residual cancerous tissue. This is particularly valuable in post-treatment evaluations, as it provides an additional layer of diagnostic information beyond the structural changes captured by MRI or other imaging modalities.

Clinical case studies presented at the European Congress of Radiology in Vienna, Austria, underscore CTLM’s utility in this context. These studies compared the sensitivity of MRI and CTLM in detecting residual angiogenesis after neoadjuvant therapy. In some cases, MRI results suggested that the tumor had responded fully to treatment, with no visible signs of remaining cancer. However, CTLM detected areas of ongoing angiogenesis that were not visible on the MRI scans, suggesting that the tumor’s vascular network had not been completely eradicated. This discrepancy highlights CTLM’s potential for uncovering residual disease that might be missed with traditional imaging techniques.

Further research conducted at the Catholic University in Rome, Italy, supports this finding, indicating that CTLM may be more sensitive than MRI in certain post-treatment scenarios. For example, one study showed that while MRI indicated a complete response to neoadjuvant therapy in a patient, CTLM revealed persistent angiogenesis in the treated area. Subsequent biopsies confirmed that cancerous tissue remained, validating CTLM’s ability to provide critical functional insights that enhance post-treatment evaluation.

This enhanced sensitivity to vascular changes is especially important for guiding further treatment decisions. In cases where CTLM detects residual angiogenesis, clinicians may choose to pursue additional interventions such as further chemotherapy, targeted radiation, or additional surgical excision. By identifying areas of concern that other imaging techniques may overlook, CTLM helps to ensure that no viable cancer cells remain post-treatment, thereby reducing the risk of recurrence and improving overall patient outcomes.

In summary, CTLM’s ability to detect residual angiogenesis following neoadjuvant therapy provides an important advantage in post-treatment monitoring. Its functional imaging capabilities allow for a more precise evaluation of the effectiveness of cancer treatment, particularly in detecting small, residual areas of cancer that might be missed by MRI. This makes CTLM a valuable tool for clinicians seeking to ensure comprehensive cancer removal and for patients undergoing treatment for locally advanced breast cancer.

One compelling case involved a patient with locally advanced breast cancer who underwent imaging both before and after receiving neoadjuvant chemotherapy. Prior to treatment, MRI scans revealed a large area of angiogenesis around the tumor, a hallmark of aggressive cancer as it indicates the tumor’s need for an extensive blood supply to sustain its rapid growth. This pattern of abnormal blood vessel formation is typically seen in highly malignant tumors. After completing chemotherapy, a follow-up MRI showed a complete resolution of the angiogenesis, suggesting that the treatment had successfully eradicated the tumor and its blood vessel network. Based on these MRI results, the initial conclusion was that the cancer had responded fully to therapy.

However, when the same patient was imaged using CTLM, a different story emerged. Despite the MRI showing no signs of remaining tumor-related blood vessels, CTLM detected residual angiogenesis within the breast tissue. This functional imaging revealed that small pockets of abnormal blood vessel formation persisted, even though the structural changes captured by the MRI suggested otherwise. The presence of residual angiogenesis indicated that a portion of the tumor likely remained, although it was no longer visible on MRI.

To confirm this finding, a follow-up biopsy was conducted on the area where CTLM had detected residual angiogenesis. The biopsy results confirmed the presence of cancerous cells, validating CTLM’s ability to detect remaining disease that had been missed by MRI. This case highlights the critical advantage of CTLM in post-treatment evaluation: while MRI is highly effective at detecting structural changes in the breast, such as tumor shrinkage, it may not always capture the full picture when it comes to functional changes like angiogenesis.

CTLM’s ability to visualize these functional aspects of cancer, such as ongoing blood vessel formation, provides crucial information about the tumor’s biological behavior and its response to therapy. Even when a tumor appears to have shrunk or disappeared on structural imaging, CTLM can reveal whether the underlying blood vessel network—often an indicator of remaining cancerous tissue—has been fully eliminated. This capability is especially important in cases of aggressive cancers, where complete eradication of the tumor’s vascular support system is necessary to prevent recurrence.

In this case, CTLM’s detection of residual angiogenesis led to a more accurate assessment of the patient’s response to treatment, prompting further clinical intervention to address the remaining cancerous tissue. This demonstrates the value of integrating CTLM into post-neoadjuvant therapy monitoring, as it provides a functional perspective that complements and enhances the structural data obtained from MRI. By revealing residual disease that might otherwise go unnoticed, CTLM plays a vital role in ensuring more comprehensive cancer treatment and improving long-term outcomes for patients.

In another case involving multifocal cancer of the left breast, both CTLM and MRI scans were initially performed before the patient underwent treatment. Prior to therapy, both imaging modalities revealed similar patterns of vascularization, indicating the presence of active tumor growth supported by a network of blood vessels. Following six cycles of neoadjuvant chemotherapy, the MRI scan suggested a complete response to the treatment, as it showed no residual angiogenesis. This implied that the therapy had successfully eradicated the tumor and its associated blood vessel network, signaling an apparent full recovery.

However, when the patient was re-evaluated using CTLM, the results told a different story. While MRI indicated no remaining signs of tumor-related vascularization, CTLM still detected angiogenesis, suggesting that tumor-related blood vessel formation persisted despite the apparent therapeutic success. This discrepancy between MRI and CTLM results prompted further investigation, leading to a histopathological examination. The biopsy revealed microfoci of invasive ductal carcinoma, confirming that residual cancerous cells were still present, even though they were not visible on the MRI scan.

This case underscores CTLM’s superior ability to detect subtle, yet critical, vascular changes that can signify residual cancer. By focusing on the blood vessels supporting tumor growth, CTLM can reveal microfoci of cancer that may evade detection by traditional imaging methods like MRI, which primarily focus on structural changes in the tissue. This is especially important in the post-treatment setting, where the complete elimination of cancerous tissue, including the tumor’s vascular network, is essential to preventing recurrence.

CTLM’s heightened sensitivity to vascular activity provides a more detailed and functional assessment of residual disease following neoadjuvant therapy. It is capable of detecting even small, persistent areas of abnormal blood flow, which can indicate that cancerous cells remain, despite the appearance of a complete response on MRI. By visualizing these subtle changes in angiogenesis, CTLM ensures that no remnants of the tumor are overlooked, enabling clinicians to make more informed decisions regarding additional treatments, such as further chemotherapy, targeted therapies, or surgery.

This ability to detect residual angiogenesis is crucial for improving patient outcomes, as it reduces the likelihood of tumor recurrence by ensuring more comprehensive treatment. CTLM’s role in post-therapy monitoring goes beyond simply verifying the structural resolution of a tumor; it offers a functional perspective that enhances the precision of breast cancer treatment evaluations. By identifying vascular changes that may indicate ongoing disease, CTLM provides a critical tool for guiding follow-up care and optimizing long-term prognosis for patients undergoing breast cancer treatment.

The CTLM system configuration:

The CTLM procedure is designed to maximize both patient comfort and imaging accuracy. The process begins with the patient lying face-down on a specialized examination bed, which allows one breast to be naturally suspended in a circular aperture within the scanning chamber. This positioning is not only comfortable for the patient but also optimizes the breast’s exposure to the scanning system, ensuring minimal movement and better image capture. The natural suspension of the breast helps maintain its shape, which is critical for accurate imaging, as it avoids the distortion that can occur with the compression used in traditional mammography.

Within the scanning chamber, a laser source and a series of highly sensitive detectors surround the breast, working together to collect detailed imaging data. The laser source emits near-infrared light, which penetrates the breast tissue, and the detectors capture the light that is scattered and absorbed by the various components of the breast, such as blood vessels, fat, and tissue. This setup allows for a comprehensive functional assessment of the breast, particularly the vascular structures that may indicate the presence of a tumor.

One of the key features of the CTLM system is its adjustable scanning ring, which accommodates breasts of different sizes. The ring adjusts to the size of the breast to ensure optimal imaging coverage, and the system’s flexibility in slice thickness is another important aspect. The standard slice thickness for imaging is set at 2 mm, which provides high-resolution cross-sectional images ideal for most cases. However, for patients with smaller breasts, the system can reduce the slice thickness to 1 mm, increasing the resolution to ensure that even the smallest details are captured. For patients with larger breasts, the system can increase the slice thickness to 4 mm, ensuring that the entire breast is scanned efficiently without compromising the overall image quality. This adaptability ensures that the imaging is tailored to the patient’s anatomy, providing accurate and reliable results across a wide range of breast sizes.

The system’s ability to adjust both the scanning ring and the slice thickness offers a level of precision that is critical in breast cancer diagnostics. By tailoring the imaging parameters to the individual patient, the CTLM system can capture more detailed and accurate images, especially in areas where traditional imaging techniques may struggle, such as in dense breast tissue. This customization not only enhances the resolution of the images but also improves the overall diagnostic accuracy, allowing radiologists to detect even subtle abnormalities in the breast tissue that could indicate early-stage cancer or other concerns.

Overall, the CTLM procedure is designed to combine patient comfort with advanced imaging technology, providing a non-invasive and highly precise method for evaluating breast tissue. The system’s ability to adjust to different breast sizes and its use of near-infrared light for functional imaging make it a powerful tool in the early detection and diagnosis of breast cancer.

Once the breast is centrally positioned within the CTLM system’s scanning ring, uniform imaging across the entire breast area is ensured, allowing for precise and consistent data capture. The system is equipped with two scanning rings, each containing 84 highly sensitive photodetectors. These detectors are crucial for capturing the detailed absorption and scattering of the laser light as it interacts with the breast tissue. As the laser beam rotates around the breast, the photodetectors collect data from every angle, capturing high-resolution images of the tissue’s internal structures, particularly focusing on areas of vascularization that may indicate the presence of a tumor.

The CTLM system completes a full 360° rotation around the breast in just 17 seconds, making the scanning process both fast and thorough. This rapid rotation ensures that all areas of the breast are imaged without prolonged exposure to the laser, enhancing patient comfort and minimizing the time required for the procedure. After each rotation, the scanning ring descends incrementally, allowing the system to capture a new slice of the breast tissue. Depending on the size and complexity of the breast, the system typically captures between 10 and 40 slices, with the entire imaging process taking approximately 10 to 12 minutes. This ability to capture multiple slices ensures that the system provides a comprehensive, layered view of the breast, improving the detection of abnormalities that may be distributed throughout the tissue.

A key feature of the CTLM system is its highly efficient image processing. While one slice is being captured, the software is simultaneously reconstructing the previous slice into a detailed 3D image, allowing for continuous imaging without delays. This real-time reconstruction prevents downtime during the procedure, eliminating any potential issues such as cable twisting or the need for system recalibration. The alternation between scanning and reconstruction ensures a smooth and seamless workflow, with the 3D image being progressively built throughout the process.

This real-time image reconstruction not only speeds up the scanning procedure but also significantly enhances the efficiency of the diagnostic process. By the time the scan is complete, the full 3D image of the breast is ready for immediate review. This rapid availability of the scan allows radiologists to assess the images without delay, facilitating faster diagnosis and potentially reducing the time between imaging and clinical decision-making. The ability to view detailed, 3D images of the breast tissue immediately after the scan provides clinicians with critical information for diagnosing potential abnormalities, planning further diagnostic tests, or deciding on treatment strategies.

Moreover, the system’s precise and continuous imaging capabilities make it particularly valuable for capturing the vascular changes associated with tumor growth. The high sensitivity of the photodetectors, combined with the fast yet thorough scanning process, enables the CTLM system to provide clear, detailed images that enhance the detection of early-stage cancers, especially in dense or heterogeneous breast tissue where traditional imaging methods may struggle. Overall, the CTLM system’s advanced technology streamlines the imaging process while delivering the high level of detail necessary for accurate breast cancer diagnosis.

The CTLM system produces highly detailed 3D images that offer multiple viewing options, significantly enhancing the ability of physicians to evaluate breast tissue from different perspectives. These 3D scans can be viewed in sagittal, axial, and coronal planes, providing a comprehensive assessment of the breast’s internal structure. This multi-plane capability is particularly important in complex cases where abnormalities might be subtle or located in areas that are difficult to evaluate using conventional imaging methods. By enabling physicians to view the breast tissue from various angles, the CTLM system ensures a more thorough examination, which can be crucial in detecting early-stage cancers or small lesions that could otherwise go unnoticed.

One of the most valuable features of the CTLM-generated images is their ability to be rotated along any axis in real time. This interactive functionality allows clinicians to manipulate the images to explore different aspects of the breast tissue, offering a level of precision that traditional 2D imaging cannot match. Real-time rotation of the 3D images provides a dynamic view of the tissue, making it easier to identify subtle abnormalities, such as irregular blood vessel formations or areas of increased vascularization, which may be early indicators of tumor growth.

The detailed volumetric models generated by CTLM represent a significant advancement in breast imaging technology. Unlike traditional imaging methods, which often focus on structural changes in the tissue, CTLM provides a functional view by highlighting blood flow and vascular activity. This capability is particularly useful in identifying angiogenesis, the formation of new blood vessels that tumors rely on for growth. By focusing on these functional characteristics, CTLM can detect early-stage tumors that may not yet cause significant structural changes in the breast tissue, giving clinicians an invaluable tool for early detection and diagnosis.

The ability to assess the breast from multiple perspectives, combined with the real-time manipulation of 3D models, enhances the accuracy and specificity of the diagnostic process. In cases where traditional 2D imaging might struggle, especially in women with dense breast tissue, the detailed 3D scans provided by CTLM offer a clearer, more complete picture of breast health. These scans allow radiologists to pinpoint areas of concern with greater precision, improving the likelihood of detecting small or early-stage tumors that might otherwise be missed.

Furthermore, the comprehensive nature of the CTLM scans aids in planning subsequent interventions. For example, surgeons can use these detailed 3D models to better understand the spatial orientation of a tumor within the breast, facilitating more precise surgical planning. Similarly, oncologists can monitor the progress of a tumor over time by comparing volumetric images, tracking changes in blood flow and vascularization that may indicate treatment response or disease progression.

In summary, the 3D imaging capabilities of the CTLM system provide clinicians with a powerful diagnostic tool that enhances breast cancer detection and assessment. By offering multiple viewing angles, real-time image manipulation, and a focus on functional tissue characteristics, CTLM represents a valuable advancement in breast imaging technology, leading to more accurate diagnoses and better patient outcomes.

Image interpretation:

The CTLM system employs a near-infrared (NIR) laser with a wavelength of 808 nm, specifically selected for its ability to be absorbed equally by both oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (deoxygenated blood). This wavelength is optimal for imaging blood-rich areas within the breast tissue, which are often linked to tumor growth. Tumors require an increased blood supply to sustain their rapid growth, making areas of high vascularization critical indicators of potential malignancies. By targeting hemoglobin, the CTLM system can effectively highlight these blood-rich regions, offering a functional view of the breast that complements traditional structural imaging techniques like mammography.

One of the challenges of using NIR light for imaging is the scattering and diffusion of photons as they pass through the tissue. Unlike X-rays, which travel in relatively straight lines, photons in NIR light can be scattered in multiple directions, making it difficult to predict their exact path and compromising image clarity. To address this, the CTLM system is equipped with multiple laser source and detector positions, strategically placed around the breast. These multiple points of data collection allow the system to better estimate the diffusion patterns of the light, thereby compensating for photon scattering and producing more accurate and high-quality 3D images of the breast tissue.

Once the light is collected by the detectors, the system’s sophisticated image reconstruction algorithm comes into play. This algorithm incorporates an inversion factor, which is essential for improving the clarity and accuracy of the reconstructed images. As the algorithm processes the data, it generates highly detailed 3D models of the breast, which can be viewed from any axis in real-time. This ability to rotate and view the tissue from multiple angles offers clinicians a comprehensive understanding of the breast’s vascular structure, enhancing their ability to detect abnormalities.

In these 3D images, areas with a high concentration of hemoglobin—indicating increased vascularization, a hallmark of tumor angiogenesis—are displayed in white. These bright regions are often where tumors or other abnormalities are located, as malignant growths tend to create new blood vessels to support their expansion. Conversely, areas with little or no vascularization, representing normal or healthy tissue, appear in shades of green or black. This contrast between blood-rich and blood-poor areas makes it easier to distinguish between normal and abnormal tissue, providing a clear visual representation of regions that may require further investigation.

This high level of contrast is critical for identifying areas of concern that might not be visible on traditional imaging methods, especially in patients with dense breast tissue where structural imaging can be less effective. By focusing on functional aspects of the tissue, such as blood flow and hemoglobin concentration, CTLM offers a unique diagnostic perspective. The ability to differentiate between highly vascularized areas and normal tissue not only aids in the detection of early-stage tumors but also helps in assessing the overall health of the breast tissue.

Overall, the CTLM system’s use of NIR light, coupled with advanced image reconstruction algorithms and multiple detector configurations, allows for the generation of high-resolution, 3D images that provide clinicians with valuable insights into the breast’s vascular architecture. This detailed functional imaging enhances the accuracy of breast cancer diagnostics and serves as a powerful tool for identifying areas that may warrant further examination or intervention.

The CTLM system offers considerable flexibility in terms of image customization and enhancement, allowing radiologists to optimize the visualization of breast tissue based on specific diagnostic needs. One of the key features is the ability to adjust the system settings to exclude irrelevant or obscuring areas, such as benign tissue or artifacts that may interfere with the clarity of the image. This ensures that only the most critical regions of the breast are highlighted for analysis, improving the efficiency and focus of the diagnostic process. By honing in on the areas that matter most, clinicians can reduce distractions and concentrate on detecting potential abnormalities.

Additionally, the CTLM system includes advanced window and level controls that allow radiologists to fine-tune image quality. These adjustments enable more precise visualization of subtle details within the breast tissue, which might otherwise be difficult to detect. For instance, slight variations in blood flow or small pockets of increased vascularization—important indicators of early-stage cancer—can be highlighted through careful manipulation of these settings. This fine-tuning capability significantly enhances the ability to identify even the most subtle anomalies, offering a higher level of diagnostic accuracy.

CTLM images are typically presented using sophisticated surface rendering techniques that provide a three-dimensional perspective on the tissue. The process begins with maximal intensity projection (MIP), a visualization mode that accentuates areas with the highest concentration of blood vessels. This is particularly useful for detecting regions of angiogenesis, where tumors often stimulate the growth of new blood vessels to support their development. MIP allows radiologists to quickly identify the most vascularized areas, which may signal abnormal growths that warrant further investigation.

Following MIP, the front-to-back reconstruction (FTB) method is employed, offering a layered view of the breast tissue. This layered approach provides depth and context to the images, enabling radiologists to explore the internal structure of the breast from different angles. By comparing the outer layers of the breast with the deeper tissue, clinicians can gain a comprehensive understanding of how blood vessels are distributed throughout the breast. This depth of analysis is crucial in distinguishing between normal vascularization and patterns that may indicate malignancy.

The combination of MIP and FTB modes provides a powerful tool for evaluating vascular patterns within the breast, which are key in identifying potential tumors. Abnormal growths often cause irregular or increased vascularization, and by analyzing these patterns, radiologists can assess whether the blood vessel distribution appears typical or if it shows signs of cancer. CTLM’s focus on the functional aspect of blood flow, rather than just structural changes in the tissue, offers a more dynamic and informative perspective, allowing for earlier detection and more accurate diagnoses.

Furthermore, the ability to manipulate and customize these visualization modes in real time enhances the overall diagnostic process. Radiologists can interact with the images, rotating and examining them from multiple perspectives, ensuring that nothing is overlooked. This flexibility, combined with the precision offered by MIP and FTB, makes CTLM an invaluable tool in breast imaging, particularly when identifying subtle or early-stage tumors that might be missed by more traditional imaging methods.

One of the distinctive features of CTLM image interpretation is the practice of blinding radiologists to the patient’s clinical history and prior imaging results during the review process. Radiologists are specially trained to analyze CTLM images purely based on the visual data provided by the scan, without any influence from previous medical information. This blinding technique ensures that their interpretation remains objective and unbiased, as they rely solely on the functional imaging of blood flow and vascular patterns detected by CTLM. By removing preconceived notions about the patient’s condition, radiologists can provide a more accurate and impartial assessment, which is especially valuable in cases where traditional imaging methods may be less effective or inconclusive.

This approach to CTLM interpretation, combined with the system’s advanced imaging capabilities, makes it a highly effective tool for detecting abnormalities in breast tissue. In cases where conventional imaging techniques like mammography might struggle—such as with dense breast tissue—the unbiased analysis provided by CTLM helps radiologists identify potential issues that might otherwise go unnoticed. The combination of cutting-edge technology and expert interpretation enhances the overall diagnostic accuracy, making CTLM an indispensable asset in breast cancer detection.

### Benign or Malignant? Angiogenesis Patterns and CTLM:

One of the primary challenges in traditional breast imaging, particularly with mammography, is the issue of tissue density. Dense or heterogeneously dense breast tissue can obscure potential abnormalities, making it difficult to detect early signs of cancer. This is a significant problem because a large percentage of women have dense breast tissue, which limits the sensitivity of mammograms in spotting tumors. However, the CTLM system effectively addresses this limitation by using near-infrared (NIR) laser technology that penetrates even extremely dense breast tissue. The laser’s ability to pass through all types of breast density, whether fatty, dense, or heterogeneous, makes CTLM a valuable tool for early detection in women who might otherwise face challenges with traditional imaging.

In addition to overcoming the issue of tissue density, CTLM focuses on angiogenesis patterns—abnormal blood vessel formation associated with tumor growth. Tumors often induce the growth of new blood vessels to support their rapid development, a process known as angiogenesis. These abnormal patterns of vascularization are key indicators of malignancy, and CTLM is designed to detect them with high sensitivity. By highlighting regions of increased blood flow and hemoglobin concentration, the system enables radiologists to differentiate between benign and malignant tissues more effectively.

Benign conditions may also show increased vascularization, but the patterns tend to differ from those associated with malignant tumors. For example, benign lesions like fibroadenomas may have more organized and regular blood vessel structures, whereas malignant tumors often present with chaotic and irregular angiogenesis. CTLM’s ability to detect and visualize these differences provides crucial information for determining whether a suspicious area is likely to be benign or malignant. This functional imaging capability enhances the overall diagnostic process by offering insights into the biological activity of the tissue, rather than just its structural characteristics.

Ultimately, CTLM’s ability to penetrate dense tissue and its focus on functional imaging of blood vessel formation make it an invaluable tool in breast cancer diagnostics. By providing a clearer view of tissue vascularization patterns, the system improves the accuracy of diagnosing benign versus malignant conditions and aids in the early detection of tumors, even in patients with challenging breast tissue composition. This combination of advanced technology and unbiased interpretation ensures that radiologists can make well-informed decisions, ultimately leading to better patient outcomes.

The CTLM system operates by focusing on the absorption patterns of hemoglobin within blood vessels, rather than on the density of the surrounding tissue. This is a crucial factor in cancer detection because angiogenesis—the formation of new blood vessels to supply tumors with oxygen and nutrients—is a key characteristic of malignancy. Tumors, particularly those in rapid growth phases, require a rich and continuous blood supply, and the abnormal blood vessels formed during this process differ significantly from normal vessels in both structure and function. These vessels are typically disorganized, irregularly shaped, and concentrated in specific regions, leading to areas of increased hemoglobin concentration.

CTLM is specifically designed to detect these areas of high hemoglobin concentration, which appear as bright white regions on the imaging scan. These bright spots correspond to areas where blood vessels are densely packed, an indicator of abnormal tissue that may be associated with cancerous growths. This focus on vascular activity rather than structural changes in the tissue itself provides a functional view of the breast, setting CTLM apart from traditional imaging methods like mammography and ultrasound, which primarily focus on structural abnormalities such as masses or calcifications.

One of the major advantages of CTLM is its ability to visualize and assess angiogenesis, even when structural changes in the breast tissue are minimal or absent. Early-stage cancers or small tumors may not cause significant alterations in tissue structure, making them difficult to detect using conventional imaging techniques. However, these tumors still exhibit abnormal vascularization, which CTLM can detect with a high degree of sensitivity. By highlighting areas of abnormal blood flow, the system enables clinicians to identify potential malignancies earlier than would be possible with structural imaging alone.

This focus on vascular changes is particularly beneficial in cases where traditional imaging methods, such as mammograms, are less effective—most notably in women with dense breast tissue. Dense tissue can obscure tumors on mammograms, making it harder to identify abnormalities. However, because CTLM relies on the functional imaging of blood vessels rather than tissue density, it is equally effective in both dense and non-dense breast tissue. This capability allows CTLM to detect potential malignancies in women for whom traditional imaging might fail to provide clear results, offering a critical advantage in early breast cancer detection.

In addition to detecting tumors at an earlier stage, CTLM’s functional imaging enhances diagnostic accuracy by providing additional insights into the biological activity of the tissue. The ability to observe abnormal vascular patterns associated with tumor growth provides clinicians with more information about the nature of the suspected abnormality, allowing for more informed decision-making regarding further testing or treatment.

By complementing traditional imaging techniques, CTLM adds a valuable functional perspective that enhances diagnostic sensitivity and accuracy. This makes it a powerful tool in the ongoing battle against breast cancer, particularly for women with dense breast tissue, where early detection is often more challenging. CTLM’s ability to provide both functional and structural insights into breast health ensures that radiologists have the comprehensive information they need to make the most accurate diagnoses and develop effective treatment plans.

Detailed studies on the CT features of malignant angiogenesis reveal that the vessels are:

1. Abnormal in shape
2. Show as isolated areas of high absorption
3. Located deep in the breast tissue

It is crucial for physicians to differentiate between normal and abnormal blood vessels during CTLM imaging, as this distinction plays a key role in identifying malignancies. In coronal views, abnormal angiogenesis—often associated with tumor growth—appears as round or ovoid areas of high absorption due to increased hemoglobin concentration. These areas are visualized in white and are easily distinguishable from normal vascular structures, which typically appear cone-shaped or triangular. On the 3D maximal intensity projection (MIP) view, abnormal angiogenesis takes on various irregular shapes, such as oblate spheres, diverticula, dumbbell shapes, or circles. These distinct formations stand in stark contrast to the smooth, tunnel-like appearance of normal blood vessels.

In the 3D-MIP view, normal vessels typically appear as “ribbons” extending from the chest wall to the nipple. Their branching pattern is often described as a “star” or “branch,” representing the normal distribution of blood flow. High absorption areas, such as those at the nipple and areola, can be visualized, but these regions are typically surrounded by a network of veins, indicating normal tissue. In contrast, blood vessels associated with malignant tumors tend to be isolated and lack the surrounding venous network. Another key distinction is that normal vessels are usually located near the surface of the breast, whereas high absorption deep within the breast tissue, as seen in CTLM imaging, often signals malignancy.

Comparing 3D-MIP and front-to-back (FTB) reconstruction modes provides a clearer understanding of the differences between surface-level and deeper tissue angiogenesis. This comparison is particularly useful in distinguishing benign surface lesions—such as adiponecrosis or mastitis, which may show superficial angiogenesis—from deeper malignant lesions. While both benign and malignant lesions can display angiogenesis, malignant tissues absorb significantly more light, with absorption rates averaging 72.15%, compared to 31.57% for benign tissues (χ2=25.558, P=.000). This marked difference in absorption levels is a key indicator for physicians when assessing potential malignancies.

When results from the CTLM scan are ambiguous or inconclusive, physicians may seek additional diagnostic information through confirmatory histological analysis. For example, micro-vessel counts can provide further insights into whether a lesion is benign or malignant. In terms of interpretive data from CTLM, a score of 1 indicates benign lesions, a score of 2 indicates malignant lesions, and a score of 0 denotes lesions that could not be conclusively classified. This scoring system aids in guiding clinical decision-making and determining the next steps in diagnosis and treatment.
[7]

Comparison Between Conventional Mammography and CTLM 3D Images: Case Study

Medio-lateral view, 51 year old on Hormone Replacement Therapy, complains of lump in the medial side of the breast. Lump was palpable at approximately  3 o’clock posteriorly. Ultrasound was equivocal.	A frontal CTLM image, with conventional MIP reconstruction, shows axial architecture and sub-areolar vascularity, (the intense white areas), both of which are normal, but there is a localized well circumscribed lucent, (avascular), area situated medially, around 3 o’clock (red arrows).
The medio-lateral CTLM view shows what appears to be a large vessel (white), extending down from the subareolar area and bifurcating around the lucent area (red arrows).	An FTB, (surface rendering), lateral CTLM image shows that the vascularity seen previously, (blue arrows), is in fact largely due to residual well-vascularized lobular tissue which has been pushed apart by a large cyst (red arrows). Confirmed by aspiration biopsy.

 

Conclusion:

CTLM is a very powerful tool to detect angiogenesis, which is indicative of tumors. It can differentiate between benign and malignant tumors. It is a feasible tool to increase the diagnostic capability of mammography. The scans can be difficult or inconclusive for the radiologists. Hence, there is always a need to have a counter-test or follow-up exam, like a biopsy, to be accurate. A CTLM alone does not give us the power to make a decision, but enhances the surety level if combined with other tests.

References:

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2. http://www.asiabiotech.com/publication/apbn/11/english/preserved-docs/1105/0279_0280.pdf
3. http://globenewswire.com/news-release/2012/12/11/510834/10015276/en/CTLM-R-3D-Laser-Breast-Imaging-System-Demonstrates-Significant-Results-When-Imaging-Dense-Breasts.html
4. http://medicalphysicsweb.org/cws/article/research/27370
5. Herranz M, & Ruibal A. Optical imaging in breast cancer diagnosis: the next evolution. Journal of oncology. 2012.
6. Chance B. Near-infrared images using continuous, phase-modulated, and pulsed light with quantitation of blood and blood oxygenation. Ann N Y Acad Sci 1998; 838:29–45.
7. Jin Q, Zhaoxiang Y. CTLM as an adjunct to mammography in the diagnosis of patients with dense breast. Clinical Imaging. 2013; 37:289–294.

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