Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract
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|ClinicalTrials.gov Identifier: NCT01112514|
Recruitment Status : Completed
First Posted : April 28, 2010
Results First Posted : February 24, 2014
Last Update Posted : February 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|High Risk Polyposis Syndrome Distal Colonic Lesions Colorectal Polyps||Drug: indocyanine green||Not Applicable|
- 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 (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||April 2013|
Experimental: ICG Injection
These participants underwent a colonoscopy after having an ICG injection.
Drug: indocyanine green
Administered intravenously during endoscopic near-infrared (NIR) imaging
- Number of Neoplastic Lesions Detected [ Time Frame: upto 15 mins ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112514
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02214|
|Principal Investigator:||Andrew T. Chan, MD, MPH||Massachusetts General Hospital|