Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract

Completed · Not applicable

Conditions studied: High Risk Polyposis Syndrome, Distal Colonic Lesions, Colorectal Polyps

In brief

Standard white light endoscopy involves the passage of a thin, flexible camera into the colon from the anus. Although standard white light endoscopy can detect most polyps and precancerous areas in the gastrointestinal tract and colon, many studies have shown that even the most experienced doctors, under optimal conditions, can miss up to 15-25% of precancerous areas. Thus, there remains a clear need to develop new methods of improving standard white light endoscopy. We are investigating whether indocyanine green (ICG) can serve to highlight areas which are precancerous when the colon is visualized with a special cameral which shines fluorescent light. Information from other studies suggests that this ICG agent may help to visualize blood vessels flowing to precancerous areas in the colon. We are looking at the ability of ICG, in combination with an endoscope which shines fluorescent light, to visualize precancerous areas in the colon.

Key facts

Study ID

NCT01112514

Run by

Massachusetts General Hospital

People needed

4

Starts

2010-02-01

Expected to finish

2013-04-01

Last updated by the study team

2014-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants will include patients with high risk polyposis syndromes with planned routine endoscopic surveillance for neoplasia or patients with planned endoscopic evaluation of distal colonic lesions suspicious for colorectal polyps or cancer detected on abdominal imaging
• Fit for conscious sedation or monitored anesthesia care for colonoscopy-American Society of Anesthesiologists (ASA) Class I or II
• 18 years of age or older
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
• Negative human chorionic gonadotropin (HCG) test for women of child-bearing age. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation

You may not qualify if…

• Participants with AsA class III, IV, V
• Documented allergy to iodine, iodine-containing compounds of ICG
• Documented allergy to sulfur containing compounds
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG
• History of adverse reactions to endoscopy or sedatives for endoscopy
• Pregnant or breast-feeding women
• Participants who are unable to discontinue warfarin anticoagulation 5 days before the procedure
• Participants taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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