Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Olympus Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| peptide application | Experimental | Investigational Agent Administration
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colon KCC Heptapeptide | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Validation of binding of peptide | 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. | One time during colonoscopy |
Not provided
Not provided
Inclusion Criteria:
OR
-Subjects with known colonic adenomas scheduled for colonic resection
OR
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28012848 | Derived | Joshi BP, Dai Z, Gao Z, Lee JH, Ghimire N, Chen J, Prabhu A, Wamsteker EJ, Kwon RS, Elta GH, Stoffel EM, Pant A, Kaltenbach T, Soetikno RM, Appelman HD, Kuick R, Turgeon DK, Wang TD. Detection of Sessile Serrated Adenomas in the Proximal Colon Using Wide-Field Fluorescence Endoscopy. Gastroenterology. 2017 Apr;152(5):1002-1013.e9. doi: 10.1053/j.gastro.2016.12.009. Epub 2016 Dec 22. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D015179 | Colorectal Neoplasms |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005759 | Gastroenteritis |