Status:
TERMINATED
Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer
Lead Sponsor:
Danielle Kim Turgeon
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
The overall aim of this feasibility study is to develop new technologies for improved detection of cholangiocarcinoma using the SFE-based molecular-imaging mini-cholangioscope (MC) system. This study ...
Eligibility Criteria
Inclusion
- Subject meets all of the following criteria:
- Scheduled for an outpatient ERCP to diagnose a potential biliary disorder (such as an indeterminate biliary stricture)
- Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities)
- Age 18 to 100 years
- Willing and able to sign informed consent
Exclusion
- Subjects with known allergy or negative reaction to any components of the study drug (list these)
- Subjects on active chemotherapy or radiation treatment
- Pregnant or trying to conceive
- 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 :
September 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04304781
Start Date
September 22 2020
End Date
December 17 2021
Last Update
November 22 2022
Active Locations (1)
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1
Michigan Medicine
Ann Arbor, Michigan, United States, 48109