Fluorescence QRH-882260 Peptide Imaging in the Bile Duct

• Status: Completed
• Trial end date: 2020-08-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: D. Kim Turgeon, MD
• Collaborator: University of Washington

Criteria

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