A Phase I In-Vivo Colon Protocol for Detection of Neoplasia in the Digestive Tract (U54)
18 Years
N/A
Both
Colon Lesions
Trial Information
A Phase I In-Vivo Colon Protocol for Detection of Neoplasia in the Digestive Tract (U54)
The goal of this research is to develop the use of fluorescence-labeled peptides (Colon KCC)
that affinity bind to pre-cancerous mucosa in the digestive tract for use as an imaging
agent to aid in the early detection of colon cancer. Currently colon cancer prevention is
achieved by endoscopic evaluation and removal of pre-malignant lesions (adenomatous polyps)
by endoscopic resection and biopsy. Standard endoscopy uses white light illumination and is
only able to detect pre-cancerous tissue that has abnormal architectural features, such as a
polyp or mass. However, pre-cancerous lesions can also be flat in appearance and visually
indistinct from normal tissue; such as in the case of chronic ulcerative colitis and / or
some right-sided polyps.
Furthermore, flat and depressed lesions, which are more difficult to detect in white light
colonoscopy, may represent over 25% of all pre-malignant lesions and may confer a higher
risk for malignancy. Integration of molecular probes that home in to diseased tissues with
high resolution imaging instruments could greatly improve the diagnostic accuracy for missed
lesions of both polypoid and non-polypoid morphology, including the often fatal 'right-sided
' adenomas.
Endoscopic imaging with the use of fluorescent-labeled probes is a promising method for
achieving greater specificity, spatial localization and higher image contrast in the
detection of neoplastic lesions. This study is a 'first-in-humans' test of the safety of
the topically applied peptide.
A Phase I study of the safety of a topically-administered fluorescent heptapeptide for
detecting neoplastic areas of the colon is proposed. The study will test the safety of
administering this agent to human subjects undergoing clinically-indicated colonoscopy.
Safety is defined as the occurrence of adverse events after the administration of topical
fluorescence-labeled peptides to the surface of intra-colonic mucosa.
Inclusion Criteria
The inclusion criteria for this proposed clinical study are:
- Subjects who are scheduled for outpatient colonoscopy.
- All subjects who are medically cleared for the procedure (e.g. washout for
anticoagulants, comorbidities) who meet the inclusion/exclusion will be included.
Standard practice guidelines for safely proceeding with the procedure will be
sufficient for our study
- Adults aged 18 years to 100
- Willing and able to sign informed consent
- Willing and able to get the repeat clinical labs
- The effects of the Colon KCC Heptapeptide (labeled with 5-FITC) on the developing
human fetus are unknown. For this reason, women of child-bearing potential must have
a negative pregnancy test on the day of the procedure 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.
The exclusion criteria for this proposed clinical study are:
- Subjects with known allergy or negative reaction to fluorescein or derivatives.
- Subjects on active chemotherapy or radiation treatment
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Application of peptide to 25 subjects undergoing colonoscopy
Outcome Description:
To evaluate the safety of topically administered fluorescence-labeled peptides to the surface of intra-colonic mucosa.
Outcome Time Frame:
6 months
Safety Issue:
Yes
Principal Investigator
Danielle Kim Turgeon, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Michigan
Authority:
United States: Food and Drug Administration
Study ID:
HUM00068009
NCT ID:
NCT01722058
Start Date:
February 2013
Completion Date:
Related Keywords:
- Colon Lesions
- peptide
- colon
- flat lesions
Name | Location |
|---|---|
| University of Michigan | Ann Arbor, Michigan 48109-0624 |
