Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer
Phase 1 In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Biliary Intra-epithelial Neoplasia
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 will combine the use of a fluorescent-labeled peptide dimer that binds specifically to know biomarkers of cholangiocarcinoma for use as a novel imaging agent to guide endoscopic biopsies. This Phase 1B study will be used to provide early evidence of efficacy for the topical application of a peptide dimer that binds to molecular targets that are specific for biliary intra-epithelial neoplasia. A dimer is needed because cancer in the biliary tract is genetically heterogeneous. QRH binds specifically to Epidermal Growth Factor Receptor (EGFR), and KSP binds specifically to Human Epithelial Growth Factor Receptor (HER2). The study will look at peptide binding in subjects having a medical condition requiring an ERCP to diagnose a potential biliary disorder. The Phase 1A first-in-human studies of safety with topical administration by ingestion of KSP/QRH dimer (HUM00141420) has been completed.
Contrast in Cell Fluorescence
Study Arms / Comparison Groups
Dimer Application with SFE imaging
Description: Subjects having a standard-of-care ERCP will have the dimer sprayed on an area of interest in the bile duct and images taken with the SFE.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
September 22, 2020
December 17, 2021
Primary Completion Date
December 17, 2021
Inclusion Criteria: 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 Criteria: - 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
18 Years - 100 Years
Accepts Healthy Volunteers
Danielle Kim Turgeon, MD, ,
Danielle Kim Turgeon
Danielle Kim Turgeon, MD, Principal Investigator, University of Michigan