Study of QRH-882260 Heptapeptide Application in the Colon

Phase IB 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 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.

Study Overview

• Status: Terminated
• Conditions: Colon Cancer Prevention
• Intervention / Treatment: Drug: QRH-882260 Heptapeptide; Device: Scanning Fiber Endoscope

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subject meets at least one of the following criteria:

• At increased risk for colorectal cancer (CRC) and colonic polyps
• Known colonic adenomas scheduled for colonic resection
• Scheduled for outpatient colonoscopy for follow up surveillance of IBD with known dysplasia or who are at high risk for high grade dysplasia
• Subject is scheduled for outpatient colonoscopy in the Medical Procedures Unit at UMHS
• Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) Standard practice guidelines for safely proceeding with the procedure will be sufficient for the study
• Age 18 to 100 years
• Willing and able to sign informed consent

Exclusion Criteria:

Subjects with known allergy or negative reaction to Cy5 (a near-infrared fluorophore) or derivatives

• Subjects on active chemotherapy or radiation treatment
• Pregnant or trying to conceive

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Topical QRH Heptapeptide Administration

Drug: QRH-882260 Heptapeptide; topical spray; fluorescently-labeled peptide composed of a 7-amino acid sequence [Gln-Arg-His-Lys-Pro-Arg-Glu] attached via a 5 amino acid linker [Gly-Gly-Gly-Ser-Lys] to a near-infrared fluorophore, Cy5. The complete peptide sequence is written as: Gln-Arg-His-Lys-Pro-Arg-Glu-Gly-Gly-Gly-Ser-Lys(Cy5)-NH2, and is abbreviated as: QRHKPRE-GGGSK-(Cy5)-NH2.; Other Names: QRH; Device: Scanning Fiber Endoscope; Endoscope used for providing the light via laser to image the area of interest in the colon after the QRH has been sprayed and rinsed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of QRH-882260 Heptapeptide administration-related adverse events	Continued monitoring of safety in subjects as measured by the number of Adverse Event (AE) assessments, severity (grade), and relationship to the study drug (any that could be related).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of QRH-882260 Heptapeptide administration for detection of polypoid and non-polypoid colonic neoplasia	The test product efficacy will be assessed by evaluating the fluorescence intensified measured from suspicious regions of colonic mucosa where the fluorescently-labeled peptide (QRH-882260) is administered. Measurement of peptide binding will be evaluated by the fluorescence intensity measured from the suspicious (target) region and normal tissues (background) to produce a target-to-background ratio.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of QRH-882260 Heptapeptide administration for detection of dysplasia in the setting of IBD	The test product efficacy will be assessed by evaluating the fluorescence intensified measured from suspicious regions of colonic mucosa where the fluorescently-labeled peptide (QRH-882260) is administered. Measurement of peptide binding will be evaluated by the fluorescence intensity measured from the suspicious (target) region and normal tissues (background) to produce a target-to-background ratio.	1 year

Collaborators and Investigators

• Sponsor: Danielle Kim Turgeon
• Investigators: Study Director: D K Turgeon, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2017
• Primary Completion (ACTUAL): July 11, 2017
• Study Completion (ACTUAL): July 11, 2017

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (ACTUAL): May 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 20, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: HUM00122077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes