Fluorescence QRH-882260 Peptide Imaging in the Bile Duct
1 other identifier
interventional
1
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedStudy Start
First participant enrolled
April 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2020
CompletedDecember 2, 2020
December 1, 2020
1.3 years
January 30, 2018
December 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment-related Adverse Events
Number of treatment-related Adverse Events when using fluorescent imaging with QRH during cholangioscopy
30 months
Secondary Outcomes (1)
Evaluation of imaging content based on the clinical diagnosis
30 months
Study Arms (1)
QRH-882260 Heptapeptide
EXPERIMENTALFive mL of reconstituted (with sterile 0.9% NaCl) QRH-882260 Cy-5-labeled heptapeptide
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- D. Kim Turgeon, MDlead
- University of Washingtoncollaborator
Study Sites (1)
University of Washington Medical Center
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Saunders, MD
Clinical Professor of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor of Medicine
Study Record Dates
First Submitted
January 30, 2018
First Posted
February 19, 2018
Study Start
April 22, 2019
Primary Completion
August 21, 2020
Study Completion
August 21, 2020
Last Updated
December 2, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share