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A Phase I In-Vivo Colon Protocol for Detection of Neoplasia in the Digestive Tract (U54)
You are invited to participate in a research study to develop new ways to look for abnormal areas/tissues of the colon. The current endoscopes used to look at the colon are very good, but if the area doesn't look different to the naked eye, then the endoscope can't improve on that. We are looking at using special fluorescent stains in addition to special endoscopes designed to see abnormal areas that are not obvious to the naked eye. Currently specialized microscopes and fluorescent stains are used in clinical laboratories but it takes several days of processing to get results. It may be very helpful to look for areas to sample for abnormal tissue during the endoscopy procedure. You are being asked to let us spray a "fluorescent peptides" into your right colon. Peptides are small chains of amino acids (the building blocks that make up proteins) linked together. Our peptide is a chain of 7 amino acids attached to a fluorescent dye called FITC (like the one used by your eye doctor). We have prepared this special "fluorescent peptide" to target and bind to any abnormal areas if present, and "glow" when a special light is used. In this study, we will apply the special fluorescent peptide by a spray catheter to your right colon to asses for safety. The colonoscope used in this study is the usual colonoscope used and is not able to see the fluorescence. This is a phase 1 study. This means that this is the first time we have used this kind of "fluorescent peptide" in people. The Food and Drug Administration (FDA) has not approved this agent, but is allowing us to test it in this study. The goal of this study is to see if there are any side effects from using the peptide. We have used a similar peptide that we've developed for the esophagus in over 40 patients without any side effects. This is the first test of this agent, so it won't be used to change how colonoscopy is done.
Details
| Lead sponsor | University of Michigan |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 25 |
| Start date | 2013-02 |
| Completion | 2013-08 |
Conditions
- Colon Lesions
Interventions
- Peptide application
Primary outcomes
- Application of peptide to 25 subjects undergoing colonoscopy — 6 months
To evaluate the safety of topically administered fluorescence-labeled peptides to the surface of intra-colonic mucosa.
Countries
United States