Real Time Optical Coherence Tomography (OCT) of Human Tissue
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.
Observational Model: Cohort, Time Perspective: Prospective
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.
One week after surgery
Stephen A Boppart, MD, PhD
University of Illinois and Diagnostic Photonics, Inc.
United States: Institutional Review Board
|Carle Foundation Hospital||Urbana, Illinois 61801|