Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | February 2010 |
| End Date: | August 2012 |
| Contact: | Andrew T. Chan, MD, MPH |
| Email: | achan@partners.org |
| Phone: | 617-724-1493 |
A Pilot Study of 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.
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.
- 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.
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.
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
- ECOG Performance status 0-2
- Negative 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
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