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| Name | Class |
|---|---|
| University of Wisconsin, Madison | OTHER |
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This study will evaluate LumaScan, an innovative polarization microscope for real time, intraoperative imaging and evaluation of the surface of excised tissue excised during Breast Conservation Surgery (BCS) for non invasive and invasive breast cancer. The investigators hypothesis is that LumaScan will be comparable for cancer detection to conventional histopathologic evaluation of the same areas of breast tissue. The real time, intraoperative images provided by LumaScan will help improve BCS and lessen the need for BCS re-excision surgeries which can lead to higher cost, poor cosmetic outcomes, reduced survival rates, and loss of confidence in the tissue conservation surgery procedure.
LumaScan is an innovative polarization microscope that uses Polarization Subtraction Imaging (PSI) technology to provide real time, intra operative, digital images of the surface of tissue removed during BCS for breast cancer. PSI uses polarized visible light for optical sectioning and geometric imaging of the superficial layers of the surgically removed tissue while rejecting surface scatter and light from deeper layers. By rejecting light from deeper tissues PSI is able to exclusively focus on the superficial tissue layers. This also results in higher resolution images than are possible with standard optical imaging. PSI is used in both reflectance and fluorescence modes. Reflectance detects morphologic abnormalities that occur in tumor progression such as increased nuclear density, angiogenesis, cellular infiltration and crowding while fluorescence detects early biochemical changes.
To enhance the contrast of tumor at the margins the investigators will use Methylene blue (MB), a dye that has been commonly used in breast surgery for mapping sentinel lymph nodes. MB can be administered peritumorally and is quickly taken up by cells in only a few minutes of exposure and its presence does not interfere with or preclude later histopathology on the same tissue specimen. A tumor specimen may also be dipped in MB post-excision to achieve tumor margin contrast enhancement and not interfere with pathologic assessment.
Previous research using PSI technology has demonstrated the value of PSI in mapping tumor boundaries of breast cancer in excised tissue specimens and in non-melanoma skin cancers and these boundaries in side by side comparisons correlate well with those marked by a pathologist on representative sections prepared using standard H&E staining procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | No Intervention | LumaScan Image Guided Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LumaScan Image Guided Surgery | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor areas shown on LumaScan images are the same as those shown on subsequent en-face pathology images. | Quantitative metrics (e.g. size or area of tumor found between the two images) will be used to to compare en-face pathology and corresponding LumaScan images from excised breast tissue margins. | From day of surgery until receipt of pathology results (upto 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologist interpretation of LumaScan images (blinded) are similar to those of histopathology images. | The Pathologists will be asked to interpret LumaScan images and corresponding histopathology images. The images will be randomly presented to the Pathologist in order to be blinded to each. | From day of surgery until receipt of pathology results (upto 2 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shabbir B Bambot, PhD | Contact | 678-907-4711 | sbambot@lumamed.com | |
| Mark Samuels, MS | Contact | 404-376-6726 | msamuels@lumamed.com |
| Name | Affiliation | Role |
|---|---|---|
| Lee G Wilke, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Surgeons interpretation of LumaScan images (blinded) are similar to those of histopathology images. | To correlate and determine the surgeons blinded interpretation of the LumaScan images, digital photographs vs. the final pathologic outcomes (post image acquisition) | From day of surgery until receipt of pathology results (upto 2 weeks) |
| Time for each margin and bi-valved image acquisition in the operating room | Duration of surgery (upto 3 hours) |
| D017437 |
| Skin and Connective Tissue Diseases |