Status:
COMPLETED
Fluorescence QRH-882260 Peptide Imaging in the Bile Duct
Lead Sponsor:
D. Kim Turgeon, MD
Collaborating Sponsors:
University of Washington
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 imag...
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. T...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, aged 18 to 65
- Scheduled for outpatient ERCP
- Understands English and is interested in participating
- Provides signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
Exclusion
- Sleep apnea or respiratory problems
- Pregnant or trying to conceive
- Known allergy or negative reaction to components of the study product(s)
- On active chemotherapy or radiation treatment
- 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
Key Trial Info
Start Date :
April 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03438435
Start Date
April 22 2019
End Date
August 21 2020
Last Update
December 2 2020
Active Locations (1)
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1
University of Washington Medical Center
Seattle, Washington, United States, 98195