Fluorescence QRH-882260 Peptide Imaging in the Bile Duct

Patients undergoing ERCP procedure with biliary stricture will have epithelial mucosa labeled with QRH-882260 fluorescence peptide that binds to EGFR. A custom mini-cholangioscope will be used to image the luminal surfaces of the biliary duct that are exposed to the fluorescence peptide. The images will be recorded and analyzed for relative fluorescence pattern and intensity and correlated to patient diagnosis and clinical outcomes.

Study Overview

• Status: Completed
• Conditions: Cholangiocarcinoma
• Intervention / Treatment: Drug: QRH-882260 Heptapeptide

Detailed Description

A Phase 1b study of the safety and efficacy of a topically-administered 7-amino acid peptide labeled with a near-infrared fluorophore Cy5 for detecting neoplastic areas of the bile duct is proposed. The study will test the safety and efficacy of administering this agent (QRH-882260 Heptapeptide) to human subjects undergoing clinically indicated ERCP for the evaluation of biliary disorders.

This is a pilot study of a single study group at a single center. The investigators intend to enroll 12 evaluable subjects. Expected enrollment is one subject every 1 month, so the study should take 12 to 24 months to complete. The expected duration of each subject's participation is 2 to 7 days.

Subjects will be recruited around their standard of care procedure. The endoscopists performing study procedures are all credentialed to do these procedures at the UWMC Digestive Health Center.

ERCP will proceed per UWMC standard of care. The endoscopists performing the procedure will evaluate the potential risk (if any) for the subject to continue with the study procedure. Five mL of the reconstituted QRH-882260 Heptapeptide (~100 μM) will be administered to the site of interest through a catheter in the standard 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 reflection-light and fluorescence will be taken with the SFE based molecular imaging mini-cholangioscope (MC) 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 is rinsed.

The area of interest identified will be biopsied at the discretion of the endoscopist per clinical care. Any specimens taken will be for clinical care only and will be sent for routine histology per UWMC standard of care.

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

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Male or female, aged 18 to 65
2. Scheduled for outpatient ERCP
3. Understands English and is interested in participating
4. Provides signed and dated informed consent form
5. Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

1. Sleep apnea or respiratory problems
2. Pregnant or trying to conceive
3. Known allergy or negative reaction to components of the study product(s)
4. On active chemotherapy or radiation treatment
5. Anything that, in the opinion of the investigator, would place the individual at increased risk or preclude the individual's full compliance with or completion of the study

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: QRH-882260 Heptapeptide; Five mL of reconstituted (with sterile 0.9% NaCl) QRH-882260 Cy-5-labeled heptapeptide	Drug: QRH-882260 Heptapeptide; Imaging agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-related Adverse Events	Number of treatment-related Adverse Events when using fluorescent imaging with QRH during cholangioscopy	30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of imaging content based on the clinical diagnosis	Images taken during the procedure will be compared to the clinical diagnosis for the subject for correlation	30 months

Collaborators and Investigators

• Sponsor: D. Kim Turgeon, MD
• Collaborators: University of Washington
• Investigators: Principal Investigator: Michael Saunders, MD, Clinical Professor of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 22, 2019
• Primary Completion (ACTUAL): August 21, 2020
• Study Completion (ACTUAL): August 21, 2020

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (ACTUAL): February 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma
• Other Study ID Numbers: HUM00130597

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: No