Study of KCC Peptide Application in the Colon
Condition: Colon Polyps; Colorectal Cancer; Inflammatory Bowel Disease (IBD)
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    


Intervention name(s): Colon KCC Heptapeptide
Intervention type(s): Biological
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening