A Pilot Study of Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract
18 Years
N/A
Both
High Risk Polyposis Syndrome, Distal Colonic Lesions, Colorectal Polyps
Trial Information
A Pilot Study of Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract
- 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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Detect a significantly greater number of neoplastic lesions
Outcome Description:
We hypothesize that the addition of fluorescent imaging agents with NIR imaging to conventional white light endoscopy will detect significantly greater number of pathologically-confirmed neoplastic lesions
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Andrew T. Chan, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
09-398
NCT ID:
NCT01112514
Start Date:
February 2010
Completion Date:
August 2012
Related Keywords:
- High Risk Polyposis Syndrome
- Distal Colonic Lesions
- Colorectal Polyps
- ICG
- indocyanine green
- Colonic Polyps
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
