Imaging epithelial tumors with an EpCAM-targeted PET tracer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm imaging study that administers the radiotracer [68Ga]Ga-PN-EpC1 followed by PET/CT in adults with suspected or diagnosed epithelial tumors. Imaging is performed before planned biopsy or surgical resection, and PET/CT findings are compared with histopathology and standard imaging to determine sensitivity and uptake correlation with EpCAM expression by immunohistochemistry. Safety is monitored by recording adverse events after tracer administration. The study enrolls patients at a single center and requires at least one measurable lesion per RECIST v1.1.

Why it matters

Who can join: the full rules

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 patients of reproductive age must agree to use effective contraception during the study and for at least 3 months after the examination.
9. Voluntarily participate in the study, demonstrate full understanding of the protocol, and provide written informed consent.

Exclusion Criteria:

1. Severe laboratory abnormalities, including significant impairment of hepatic or renal function, or severe hematological dysfunction.
2. History of allergic diseases.
3. Patients planning for pregnancy during the study period.
4. Pregnant or lactating women.
5. Inability to maintain a supine position for at least 30 minutes.
6. Patients with claustrophobia or other diagnosed psychiatric disorders that may interfere with compliance.
7. Any other condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the evaluation of the study results.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.