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NCT Number: NCT07400263

Evaluation of an EpCAM-Targeted Radiotracer in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Xing Yang

CONTACT

[email protected]

00-86-010-‭88316643‬

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

[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.

Primary outcomes

  1. Sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for lesion detection

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

    Sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for detecting epithelial tumor lesions, using histopathological results as the reference standard.

Secondary outcomes

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

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

    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.

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

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

    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).

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

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

    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.

Other outcomes

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

    Time frame: From initial imaging assessment to the end of follow-up at 2 years.

    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.

  2. Optimal Cut-off Value of [68Ga]Ga-PN-EpC1 Uptake for Predicting Tumor Lesions

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

    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.

  3. Correlation of Tracer Uptake and Total Tumor Burden with Patient Prognosis

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

    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).

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 10, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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