NCT07400263

Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors

A Prospective Clinical Study of an EpCAM-Targeted Radiotracer for Molecular Imaging of Epithelial Tumors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epithelial Tumors, Malignant

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	[68Ga]Ga-PN-EpC1 PET/CT	Participants will receive a single intravenous administration of the EpCAM-targeted radiotracer \[68Ga\]Ga-PN-EpC1 for PET/CT imaging. The radiotracer will be administered at a dose of 0.05-0.1 mCi/kg, followed by whole-body PET/CT acquisition according to the study imaging protocol. Additional dynamic or delayed imaging may be performed in selected participants.

Timeline

• Start date: 2026-03-04
• Primary completion: 2027-06-30
• Completion: 2028-12-31
• First posted: 2026-02-10
• Last updated: 2026-03-30

Locations

1 site across 1 country: China