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NCT03148119 · ClinicalTrials.gov registry record · Phase 1
Study of QRH-882260 Heptapeptide Application in the Colon
A Phase 1 study, sponsored by Danielle Kim Turgeon.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT03148119 is a Phase 1 study that was terminated before completion, run by Danielle Kim Turgeon. The registered enrollment target is 5 participants.
The verdict
NCT03148119, a Phase 1 study, was terminated before completion, sponsored by Danielle Kim Turgeon.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
A Phase 1B study of the efficacy of a topically-administered 7-amino acid peptide labeled with a near-infrared fluorophore Cy5 for detecting neoplastic areas of the colon is proposed. The study will test the efficacy of administering this agent (QRH-882260 Heptapeptide) to human subjects undergoing clinically-indicated colonoscopy for endoscopic resection of known colonic adenomas or for surveillance biopsies of known dysplasia in the setting of irritable bowel disease (IBD). Up to 120 evaluable subjects will be enrolled. Subjects will be recruited around scheduled standard of care procedures. The endoscopists performing the procedures are all endoscopists credentialed at the University of Michigan to do these procedures. Urine for dipstick pregnancy testing (if applicable) will be collected before the procedure, along with medical information. Vital signs are routinely monitored throughout the clinical procedure and are available in the electronic medical record. The endoscopy will proceed per the University of Michigan Health System (UMHS) standard of care. The endoscopist performing the clinical procedure will evaluate the potential risk (if any) for the subject to continue with the procedure or study. Five mL of the reconstituted QRH-882260 Heptapeptide (\~100 μM) will be sprayed onto the site of interest through a catheter in the endoscope. Five minutes after QRH-882260 Heptapeptide application, the unbound peptide will be washed off using the endogator irrigator and the residual liquid will be suctioned. Pictures with white-light and fluorescence will be taken with the scanning fiber based molecular imaging endoscopic probe inserted via the instrument channel of the standard endoscope before the QRH-882260 Heptapeptide application, immediately after application and then again after the QRH-882260 Heptapeptide will be washed off. The area of interest identified will be resected/biopsied per discretion of the endoscopist per clinical care. All specimens taken a
Interventions
- DRUG QRH-882260 Heptapeptide
- DEVICE Scanning Fiber Endoscope
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-03-31 |
| Est. Completion | 2017-07-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03148119
The ClinicalTrials.gov registry entry for NCT03148119 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Danielle Kim Turgeon, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which QRH-882260 Heptapeptide is the first listed.
NCT03148119 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03148119 about?
NCT03148119 is a clinical study titled "Study of QRH-882260 Heptapeptide Application in the Colon". A Phase 1B study of the efficacy of a topically-administered 7-amino acid peptide labeled with a near-infrared fluorophore Cy5 for detecting neoplastic areas of the colon is proposed. The study will test the efficacy of administering this agent (QRH-882260 Heptapeptide) to human subjects undergoing ...
What is the current status of trial NCT03148119?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2017-03-31. Estimated completion is 2017-07-11.
What interventions are being tested in trial NCT03148119?
The interventions under investigation include: QRH-882260 Heptapeptide (DRUG), Scanning Fiber Endoscope (DEVICE).
Who is sponsoring clinical trial NCT03148119?
This trial is sponsored by Danielle Kim Turgeon, which has 4 total clinical trials registered on ClinicalTrials.gov.
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