Imaging epithelial tumors with an EpCAM-targeted PET tracer

A Prospective Clinical Study of an EpCAM-Targeted Radiotracer for Molecular Imaging of Epithelial Tumors

This test uses a new EpCAM-targeted PET tracer, [68Ga]Ga-PN-EpC1, to see if it safely detects EpCAM-positive tumors in adults scheduled for biopsy or surgical treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University People's Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07400263 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (over 18) with suspected or confirmed epithelial tumors who are scheduled for biopsy or surgical treatment within two months, have at least one measurable lesion, and meet basic organ-function and life-expectancy requirements.

Not a fit: Patients whose tumors do not express EpCAM, those not undergoing biopsy or surgery, people with poor organ function or life expectancy under 12 weeks, and pregnant women are unlikely to benefit from this imaging test.

Why it matters

Potential benefit: If successful, the tracer could improve detection and staging of EpCAM-positive epithelial tumors and help target biopsies or surgeries more accurately.

How similar studies have performed: EpCAM-targeted imaging is relatively novel; preclinical work and small early clinical reports have shown promise but large-scale clinical validation is limited.

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 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 this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Conditions: Epithelial Tumors, Malignant