Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors

NCT07400263 | Recruiting DMC

• 1 other identifier: 2025PHB625
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Epithelial Tumors, Malignant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Specificity and Accuracy of [68Ga]Ga-PN-EpC1 PET/CT for Lesion Detection

  From PET/CT imaging to histopathological confirmation within 2 months.

• Correlation Between [68Ga]Ga-PN-EpC1 Uptake and EpCAM Expression Levels

  From PET/CT imaging to IHC analysis of biopsy or surgical specimens (within 2 months).

• Safety of [68Ga]Ga-PN-EpC1 PET/CT Imaging

  Within 72 hours post-injection of [68Ga]Ga-PN-EpC1.

Other Outcomes (3)

• Comparative Diagnostic Performance: Standard Structural Imaging vs. [68Ga]Ga-PN-EpC1 PET/CT

  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

  From PET/CT imaging to the end of follow-up at 2 years.

• Correlation of Tracer Uptake and Total Tumor Burden with Patient Prognosis

  From PET/CT imaging to the end of follow-up at 2 years.

Study Arms (1)

EpCAM PET

EXPERIMENTAL

Diagnostic Test: [68Ga]Ga-PN-EpC1 PET/CT

Interventions

[68Ga]Ga-PN-EpC1 PET/CT DIAGNOSTIC_TEST

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.

EpCAM PET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Normal cardiac function.
• Expected life expectancy ≥12 weeks.
• Presence of at least one measurable target lesion according to RECIST v1.1 criteria.
• Patients recommended by clinicians to undergo PET/CT examination for tumor diagnosis and staging.
• 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.
• Voluntarily participate in the study, demonstrate full understanding of the protocol, and provide written informed consent.

You may not qualify if:

• 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.
• Inability to maintain a supine position for at least 30 minutes.
• Patients with claustrophobia or other diagnosed psychiatric disorders that may interfere with compliance.
• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CN (1)