Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Epithelial Tumors, Malignant
• Intervention / Treatment: Diagnostic test: [68Ga]Ga-PN-EpC1 PET/CT

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Xing Yang; Phone Number: 00-86-010-‭88316643‬; Email: yangxing2017@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: EpCAM PET

Diagnostic test: [68Ga]Ga-PN-EpC1 PET/CT; Participants will receive a single intravenous administration of the EpCAM-targeted radiotracer [68Ga]Ga-PN-EpC1 for PET/CT imaging. The radiotracer will be administered at a dose of 0.05-0.1 mCi/kg, followed by whole-body PET/CT acquisition according to the study imaging protocol. Additional dynamic or delayed imaging may be performed in selected participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for lesion detection	Sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for detecting epithelial tumor lesions, using histopathological results as the reference standard.	From PET/CT imaging to histopathological confirmation within 2 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity and Accuracy of [68Ga]Ga-PN-EpC1 PET/CT for Lesion Detection	The specificity and overall diagnostic accuracy of [68Ga]Ga-PN-EpC1 PET/CT in identifying epithelial tumor lesions, using histopathological results as the reference standard.	From PET/CT imaging to histopathological confirmation within 2 months.
Correlation Between [68Ga]Ga-PN-EpC1 Uptake and EpCAM Expression Levels	To evaluate the correlation between the intensity of tracer uptake (e.g., SUVmax, SUVmean) on PET/CT images and the expression level of EpCAM in tumor tissues as determined by immunohistochemistry (IHC).	From PET/CT imaging to IHC analysis of biopsy or surgical specimens (within 2 months).
Safety of [68Ga]Ga-PN-EpC1 PET/CT Imaging	Assessment of the incidence and severity of adverse events (AEs) related to the administration of [68Ga]Ga-PN-EpC1, monitored via vital signs and patient reporting.	Within 72 hours post-injection of [68Ga]Ga-PN-EpC1.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative Diagnostic Performance: Standard Structural Imaging vs. [68Ga]Ga-PN-EpC1 PET/CT	Comparison of diagnostic efficacy (sensitivity, specificity, accuracy) between conventional imaging (e.g., CT, MRI, FDG PET/CT) and [68Ga]Ga-PN-EpC1 PET/CT at the patient-level, region-level, and lesion-level.	From initial imaging assessment to the end of follow-up at 2 years.
Optimal Cut-off Value of [68Ga]Ga-PN-EpC1 Uptake for Predicting Tumor Lesions	To determine the optimal threshold (cut-off value) of PET semi-quantitative parameters (e.g., SUV max) for distinguishing malignant from benign lesions using Receiver Operating Characteristic (ROC) curve analysis.	From PET/CT imaging to the end of follow-up at 2 years.
Correlation of Tracer Uptake and Total Tumor Burden with Patient Prognosis	To explore the association between [68Ga]Ga-PN-EpC1 PET/CT parameters (uptake intensity, tumor volume) and patient outcomes, such as Progression-Free Survival (PFS) or Overall Survival (OS).	From PET/CT imaging to the end of follow-up at 2 years.

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: 2025PHB625

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No