XCancer

Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors

Description:

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

Government Study Link:

NCT07400263 - Click here to see study on

ClinicalTrials.gov

PN-EpC1

Isotope(s):
Target(s):
  • EpCAM
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.