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Real Time Optical Coherence Tomography (OCT) of Human Tissue

2014-08-27 04:00:30 | BioPortfolio

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.

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Breast Cancer

Intervention

Optical Coherence Tomography

Location

Carle Foundation Hospital
Urbana
Illinois
United States
61801

Status

Recruiting

Source

Diagnostic Photonics, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:30-0400

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