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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02207179.
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.
