Study of KCC Peptide Application in the Colon
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Irritable Bowel Syndrome (IBS), Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 12/17/2016 |
| Start Date: | June 2014 |
| End Date: | August 2016 |
Phase 1B 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.
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.
Inclusion Criteria:
- Subjects felt to be at increased risk for CRC and colonic polyps
OR
-Subjects with known colonic adenomas scheduled for colonic resection
OR
- 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
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