Clinical Trial

Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors

Recruiting
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Summary
The goal of this prospective, single-arm clinical trial is to evaluate the imaging performance and safety of an EpCAM-targeted radiotracer, \[68Ga\]Ga-PN-EpC1, in patients with epithelial tumors. The main questions it aims to answer are: * What is the sensitivity of \[68Ga\]Ga-PN-EpC1 PET/CT for detecting EpCAM-positive tumor lesions? * How does the radiotracer uptake correlate with EpCAM expression assessed by immunohistochemistry? * Is \[68Ga\]Ga-PN-EpC1 safe and well tolerated when administered for PET/CT imaging in patients with epithelial tumors? Participants will undergo \[68Ga\]Ga-PN-EpC1 PET/CT imaging prior to tumor biopsy or surgical resection. Imaging findings will be analyzed and compared with histopathological results and standard imaging assessments. Safety will be evaluated by monitoring adverse events following radiotracer administration.
Protocol Amendment History 1 change
critical Recruitment opened 2026-03-31
Trial Details
NCT Number NCT07400263
Lead Sponsor Peking University People's Hospital
Conditions Epithelial Tumors, Malignant
Enrollment 30 participants
Start Date 2026-03-04
Primary Completion 2027-06-30 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-30