Study of KCC Peptide Application in the Colon

We are studying new ways to look for abnormal areas/tissues of the colon during a colonoscopy. The current scopes used for colonoscopies are very good. But if the area doesn't look different to the naked eye, then the scope can't improve on that. We are using special stains or dyes and special scopes to see abnormal areas that are hard to see with the naked eye. The stain or dye is "fluorescent", meaning it glows when special light is used in the colonoscopy scope.

You are being asked to let us spray a peptide with a fluorescent tag onto your colon. Peptides are small chains of amino acids (the building blocks that make up proteins) linked together. The peptide we use has 7 amino acids attached to a fluorescent tag ("FIT C" or Fluoresceinisothiocyanate). FITC is used by eye doctors to examine your eyes (the yellow eye drops).

We are testing this "fluorescent peptide" to see if it will stick if there are any abnormal areas. If the peptide "sticks", it will "glow" when a special light in the scope is used. In this study, we will apply the fluorescent peptide to your colon by using a spray tube that fits in the colonoscope.

This is a phase IB study. This means that although we have applied the peptide to 25 people in our first research study, we still need to learn more about "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 main goal of this study is to see if the peptide "glows" well and if we can take pictures of areas that do glow.

This is a research study of the peptide and our ability to see it "glow or fluoresce". Being in this study and applying the peptide won't change how our biopsies are taken or how your colonoscopy is done.

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Key information

Conditions

Colon Polyps Colonic Diseases Colonic Polyps Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammatory Bowel Disease (IBD) Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects felt to be at increased risk for CRC and colonic polyps

-Subjects with known colonic adenomas scheduled for colonic resection

Subjects who are scheduled for outpatient colonoscopy for follow up surveillance of IBD with known dysplasia or who are at high risk for high grade dysplasia.
Subjects who are scheduled for outpatient colonoscopy in the medical procedures unit at the University of Michigan Health Center
All subjects who are medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) who meet the inclusion/exclusion criteria will be included. Standard practice guidelines for safely proceeding with the procedure will be sufficient for our study
Adults aged 18 to 100 years
Willing and able to sign informed consent
The effects of Colon KCC Heptapeptide (5-FITC-labeled peptide) on the developing human fetus are unknown. For this reason, women of childbearing potential must have a negative pregnancy test on the day of the procedure prior to receiving the Colon KCC Heptapeptide (5-FITC-labeled peptide agent) or be post-menopausal. Post-menopausal women are defined as post-hysterectomy, or over 40 and at least 18 months without menses and not on birth-control.

Exclusion criteria

Subjects with known allergy or negative reaction to fluorescein or derivatives.
Subjects on active chemotherapy or radiation treatment
Pregnant or trying to conceive

Treatment and study plan

Colon KCC Heptapeptide

Biological

Your colonoscopy will happen as it would normally, including the medications, the colonoscope, and any clinically indicated biopsies or polypectomies.
The fluorescent peptide will be sprayed on to the walls of your colon around the areas that might have a polyp, areas of IBD, or another area of interest. Your doctor will select one area to apply the peptide in your colon. The peptide comes in a single-use sealed vial from the investigational pharmacy. Sterile saline (salt-water) is added to the vial. The powder is mixed well and pulled into a syringe. The peptide is then "injected" into a special, single-use "sprayer", like a garden hose, that fits down the endoscope channel. The peptide will be sprayed in your colon. This is part of the study.
The endoscopist will take pictures of the area before and after the peptide spraying. They will use the camera that is part of the colonoscope.
We will obtain copies of your endoscopy report and any pathology reports.

Primary outcomes

Validation of binding of peptide

Time frame: One time during colonoscopy

The peptide will be applied during colonoscopy to areas that appear abnormal with white light endoscopy. The peptide fluorescence will be assessed via imaging to assess specificity of binding as compared to standard of care pathology interpretation of tissue.

Sponsors and collaborators

Lead sponsor

Danielle Kim Turgeon

Other

Collaborators

Olympus Corporation

Registry information

Official study title

Phase 1B Study of KCC Peptide Application in the Colon

Acronym: KCC 1B

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jun 5, 2014
Registry last updated: Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed