TheranosticTrials.org

Clinical Trial · NCT07400263

Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors

Overview

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.

Sponsor

Peking University First Hospital

Phase

N/A

ClinicalTrials.gov

NCT07400263

Drug / Compound

PN-EpC1

Isotope(s):
Target(s):
  • EpCAM

Eligibility

Inclusion

  • Adequate organ and bone marrow function as defined by the following laboratory values:
  • Age \> 18 years, regardless of gender.
  • Hematology: WBC ≥4.0×10\^9/L or ANC ≥1.5×10\^9/L; PLT ≥100×10\^9/L; Hemoglobin ≥90 g/L.
  • 1. Patients with diagnosed or suspected tumors visiting the hospital between January 2026 and December 2026, who are scheduled for pathological biopsy or surgical treatment within 2 months.
  • Liver Function: Total bilirubin ≤1.5× ULN; ALT and AST ≤2.5× ULN (or ≤5× ULN if liver metastases are present).

Exclusion

  • Inability to maintain a supine position for at least 30 minutes.
  • 1. Severe laboratory abnormalities, including significant impairment of hepatic or renal function, or severe hematological dysfunction.
  • Patients planning for pregnancy during the study period.
  • Pregnant or lactating women.
  • History of allergic diseases.