Primary Outcome Measures:
- The sensitivity and specificity of Optical Coherence Tomography to identify whether or not tumor can be identified ex vivo on breast cancer specimens as compared to post-surgical histology conclusions. [ Time Frame: One week after surgery ] [ Designated as safety issue: No ]
Device: Optical Coherence Tomography
Optical coherence tomography will be used to image tissue structure on excised and in vivo specimens.
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.