- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01112514
Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract
January 8, 2014 updated by: Andrew T. Chan, MD, MPH, Massachusetts General Hospital
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
- 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.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02214
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ICG Injection
These participants underwent a colonoscopy after having an ICG injection.
|
Administered intravenously during endoscopic near-infrared (NIR) imaging
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Neoplastic Lesions Detected
Time Frame: upto 15 mins
|
upto 15 mins
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
April 27, 2010
First Submitted That Met QC Criteria
April 27, 2010
First Posted (Estimate)
April 28, 2010
Study Record Updates
Last Update Posted (Estimate)
February 24, 2014
Last Update Submitted That Met QC Criteria
January 8, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 09-398
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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