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Gastroenterology Research and Practice
Volume 2016, Article ID 6184842, 7 pages
Clinical Study

Pilot Clinical Trial of Indocyanine Green Fluorescence-Augmented Colonoscopy in High Risk Patients

1Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA 02114, USA
2Department of Interventional Radiology, Division of Diagnostic Imaging, MD Anderson Cancer Center, Houston, TX 77030, USA
3Cancer Treatment Centers of America, Southeastern Regional Medical Center, Atlanta, GA 30265, USA
4Division of Gastroenterology, Massachusetts General Hospital, Boston, MA 02114, USA
5Clinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA 02114, USA

Received 20 December 2015; Accepted 24 January 2016

Academic Editor: Paolo Gionchetti

Copyright © 2016 Rahul A. Sheth et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


White light colonoscopy is the current gold standard for early detection and treatment of colorectal cancer, but emerging data suggest that this approach is inherently limited. Even the most experienced colonoscopists, under optimal conditions, miss at least 15–25% of adenomas. There is an unmet clinical need for an adjunctive modality to white light colonoscopy with improved lesion detection and characterization. Optical molecular imaging with exogenously administered organic fluorochromes is a burgeoning imaging modality poised to advance the capabilities of colonoscopy. In this proof-of-principle clinical trial, we investigated the ability of a custom-designed fluorescent colonoscope and indocyanine green, a clinically approved fluorescent blood pool imaging agent, to visualize polyps in high risk patients with polyposis syndromes or known distal colonic masses. We demonstrate (1) the successful performance of real-time, wide-field fluorescence endoscopy using off-the-shelf equipment, (2) the ability of this system to identify polyps as small as 1 mm, and (3) the potential for fluorescence imaging signal intensity to differentiate between neoplastic and benign polyps.