title: Pilot Clinical Trial of Indocyanine Green Fluorescence-Augmented Colonoscopy in High Risk Patients.
abstract: 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.
authors.affiliation: Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA 02114, USA; Department of Interventional Radiology, Division of Diagnostic Imaging, MD Anderson Cancer Center, Houston, TX 77030, USA.
authors.forename: Rahul A
authors.initials: RA
authors.lastname: Sheth
authors.affiliation: Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Pedram
authors.initials: P
authors.lastname: Heidari
authors.affiliation: Cancer Treatment Centers of America, Southeastern Regional Medical Center, Atlanta, GA 30265, USA; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Woods
authors.affiliation: Division of Gastroenterology, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Chung
authors.affiliation: Division of Gastroenterology, Massachusetts General Hospital, Boston, MA 02114, USA; Clinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Andrew T
authors.initials: AT
authors.lastname: Chan
authors.affiliation: Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Umar
authors.initials: U
authors.lastname: Mahmood