NCT03148119

Study of QRH-882260 Heptapeptide Application in the Colon

Terminated Phase 1 Last updated 24 April 2018

What this trial tests

Phase 1 trial testing QRH-882260 Heptapeptide in Colon Cancer Prevention in 5 participants. Terminated before completion.

Timeline

31 March 2017

Primary endpoint
11 July 2017

11 July 2017

Quick facts

Lead sponsor	Danielle Kim Turgeon
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	5
Start date	31 March 2017
Primary completion	11 July 2017
Estimated completion	11 July 2017
Sites	1 location across United States

Drugs / interventions tested

• QRH-882260 Heptapeptide — full drug profile →
• Scanning Fiber Endoscope

Conditions studied

• Colon Cancer Prevention — all drugs for Colon Cancer Prevention →

Sponsor

Danielle Kim Turgeon — full company profile →

Who can join

Adults 18 to 100, any sex, with Colon Cancer Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 are for clinical care only (not research use) and will be sent for routine histology per UMHS standard of care.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fluorescence Image-Guided Surgery - a Perspective on Contrast Agent Development.
   Barth CW, Gibbs SL. · · 2020 · cited 79× · PMID 32255887 · DOI 10.1117/12.2545292
2. Targeted Optical Imaging Agents in Cancer: Focus on Clinical Applications.
   Joshi BP, Wang TD. · · 2018 · cited 63× · PMID 30224903 · DOI 10.1155/2018/2015237
3. Short Linear Motifs in Colorectal Cancer Interactome and Tumorigenesis.
   Fasano C, Grossi V, Forte G, Simone C. · · 2022 · cited 5× · PMID 36496998 · DOI 10.3390/cells11233739