Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology

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.

Inclusion Criteria:

1. Women referred for breast conservation surgery following a diagnosis of invasive or
in situ carcinoma of the breast by histopathology or women referred for lumpectomy
due to a benign (fibroadenoma or papilloma) or high risk breast lesion(Atypical
ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in-situ, atypical
papilloma).

2. 18 years of age or older.

3. Able to read or understand and give informed consent.

Exclusion Criteria:

1. Patients undergoing neo-adjuvant systemic therapy.

2. Previous breast cancer and /or radiation in the operated breast.

3. Implants in the operated breast.

4. Pregnant or Lactating.

5. History of photosensitizing disease (porphyria, lupus etc.) or of allergy to
methylene blue dye.

6. Recent use of photosensitizing agents such as fluoroquinolones and retinoids or
patients undergoing phototherapy.

7. Participation in any other intraoperative margin assessment protocol that would
affect data acquisition.

8. Subareolar location (cancer is directly and completely under the nipple/areolar
complex) of breast abnormality.

9. Patients for whom English is not their native language