Cholangiocarcinoma
Conditions
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 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.
Interventions
DRUGKSP/QRH dimer
Peptide 919288G, Lot No. 17081402, Molecular Weight 3577.0, ≥95% purity. Stored at \<20°C. Dark green, lyophilized powder in single-use amber vials.
Sponsors
Danielle Kim Turgeon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast in Cell Fluorescence | During and immediately after procedure, generally no more than 2 hours | The fluorescence intensity will be measured by the target/background (T/B) ratio from suspicious regions of bile duct where the fluorescent-labeled peptide is administered. The intensity of the fluorescence of the abnormal tissue compared to the background tissue intensity will be analyzed using statistical analysis for significance comparing the tissue groups' mean T/B ratios. |
Countries
United States
Outcome results
None listed