A Phase I In-Vivo Peptide Applied in the Right Colon
Public ClinicalTrials.gov record NCT01722058. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I In-Vivo Colon Protocol for Detection of Neoplasia in the Digestive Tract (U54)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01722058
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2013
- Primary completion
- May 31, 2013
- Completion
- Jul 31, 2013
- Last update posted
- Nov 14, 2013
2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48103 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01722058, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 14, 2013 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01722058 live on ClinicalTrials.gov.