Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors
ConditionEpithelial Tumors, Malignant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital
About this trial
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
Qualifiers
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.
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.
Liver Function: Total bilirubin ≤1.5× ULN; ALT and AST ≤2.5× ULN (or ≤5× ULN if liver metastases are present).
Disqualifiers
Severe laboratory abnormalities, including significant impairment of hepatic or renal function, or severe hematological dysfunction.
History of allergic diseases.
Patients planning for pregnancy during the study period.
Pregnant or lactating women.
Trial design
Treatments tested in this trial
- [68Ga]Ga-PN-EpC1 PET/CT
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov