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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Detect a significantly greater number of neoplastic lesions
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
Andrew T. Chan, MD, MPH
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|