Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 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. 2. Age \> 18 years, regardless of gender. 3. Adequate organ and bone marrow function as defined by the following laboratory values: * Hematology: WBC ≥4.0×10\^9/L or ANC ≥1.5×10\^9/L; PLT ≥100×10\^9/L; Hemoglobin ≥90 g/L. * Liver Function: Total bilirubin ≤1.5× ULN; ALT and AST ≤2.5× ULN (or ≤5× ULN if liver metastases are present). * Renal Function: BUN ≤1.5× ULN; Serum Creatinine (SCr) ≤1.5× ULN. 4. Normal cardiac function. 5. Expected life expectancy ≥12 weeks. 6. Presence of at least one measurable target lesion according to RECIST v1.1 criteria. 7. Patients recommended by clinicians to undergo PET/CT examination for tumor diagnosis and staging. 8. Women of childbearing potential must have a negative pregnancy test within 7 days prior to the examination. Male and female patie