Real Time Optical Coherence Tomography (OCT) of Human Tissue
Real Time Optical Coherence Tomography (OCT) of Human Tissue
This is a single-arm, prospective, study of an optical imaging device on approximately twenty
 (20) subjects undergoing lumpectomies at one study site. In vivo and ex vivo imaging will be
 performed on study subjects with results being compared to final pathology.
This study is a single-center, prospective, two-part open label study of an optical imaging
 device on approximately twenty (20) subjects at one (1) study site. Patients scheduled to
 undergo a lumpectomy will be recruited by the clinical investigators at the investigational
 site in accordance with the inclusion and exclusion criteria. The study period per subject is
 the time it takes to assess the in vivo and ex vivo breast tissue samples using the study
 device during their lumpectomy.

 All specimens will be marked with India ink and undergo standard post-operative histology,
 and digital histology images corresponding to the inked locations will be obtained. The
 images and the matched digitized post-operative histology images will then be randomized and
 read by a blinded, independent pathologist. Sensitivity and specificity will be calculated.
Inclusion Criteria:

 1. Women 18 years of age or older

 2. Signed ICF

 3. Women who have been histologically diagnosed with invasive ductal carcinoma or
 invasive lobular carcinoma of the breast prior to surgery

 4. Planning breast preservation

 5. Patients undergoing lumpectomy (partial mastectomy) procedure

 Exclusion Criteria:

 1. Multicentric disease (histologically diagnosed cancer in two different quadrants of
 the breast)

 2. Neoadjuvant systemic therapy

 3. All T4 tumors

 4. Previous radiation in the operated breast

 5. Prior surgical procedure in the same quadrant

 6. Implants in the operated breast

 7. Pregnancy

 8. Lactation

 9. Participating in any other investigational study for either drug or device which can
 influence collection of valid data under this study