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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Real Time Optical Coherence Tomography (OCT) of Human Tissue|
- 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 ]
|Study Start Date:||May 2012|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Device: Optical Coherence Tomography
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506700
|Contact: Barbara Hall, BS||217-383-6199||Barbara.Hall@carle.com|
|United States, Illinois|
|Carle Foundation Hospital||Recruiting|
|Urbana, Illinois, United States, 61801|
|Contact: Barbara Hall, BS 217-383-6199 Barbara.Hall@carle.com|
|Sub-Investigator: Kimberley Cradock, MD|
|Principal Investigator: Partha Ray, MD|
|Study Chair:||Stephen A Boppart, MD, PhD||University of Illinois and Diagnostic Photonics, Inc.|