Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract

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.

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Key information

Conditions

High Risk Polyposis Syndrome Colorectal Polyps Distal Colonic Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

About this study

Participants will be scheduled for their regular lower endoscopy. On the day of the procedure, participants will come to the endoscopy unit at Massachusetts General Hospital. After arriving, participants will receive an intravenous line and meet with the research doctor to go over the procedure. The participant will then be transferred to the endoscopy procedure room and be administered sedatives until they are comfortable to proceed with the procedure.
The research doctor will pass the flexible study sigmoidoscope into the lower part of the rectum. At this time, a dose of the ICG contrast agent will be administered through the intravenous line. Any areas that are suspicious will be photographed using the camera in the scope. We will also biopsy/remove any suspicious areas and send it to the pathologist as we normally do during endoscopy.
Over the course of the study procedure, small doses of ICG will be administered to help find any precancerous areas. Altogether, the study exam should not take more than 10 to 15 minutes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Indocyanine green

Drug

Administered intravenously during endoscopic near-infrared (NIR) imaging

Other names: ICG, IC-Green

Primary outcomes

Number of Neoplastic Lesions Detected

Time frame: upto 15 mins

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

Damon Runyon Cancer Research Foundation
Dana-Farber Cancer Institute
National Cancer Institute (NCI)

Registry information

Official study title

A Pilot Study of Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2013
First posted: Apr 28, 2010
Registry last updated: Feb 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed