Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract

Colorectal Polyps Clinical Trial

Official title: A Pilot Study of Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Polyps
• Distal Colonic Lesions
• High Risk Polyposis Syndrome

• NCT number: NCT01112514
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Completion date: April 2013