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Fluorescence QRH-882260 Peptide Imaging in the Bile Duct

NCT03438435 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-12-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

QRH-882260 Heptapeptide

Imaging agent

Sponsors & Collaborators

Principal Investigators

  • Michael Saunders, MD · Clinical Professor of Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2020-08-21
Completion
2020-08-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03438435 on ClinicalTrials.gov