Real Time Optical Coherence Tomography (OCT) of Human Tissue

Breast Cancer Clinical Trial

Official title: Real Time Optical Coherence Tomography (OCT) of Human Tissue

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Breast Cancer

• NCT number: NCT01506700
• Study type: Observational
• Source: Diagnostic Photonics, Inc.
• Status: Terminated
• Start date: May 2012
• Completion date: July 17, 2019