Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [68Ga]Ga-PN-EpC1 PET/CT.
- Who it may be relevant to
- Registry conditions: Epithelial Tumors, Malignant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Clinical Study of an EpCAM-Targeted Radiotracer for Molecular Imaging of Epithelial Tumors
Overview
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.
Interventions
- 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.
Primary outcome measures
- Sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for lesion detection [Time frame: From PET/CT imaging to histopathological confirmation within 2 months.]
Secondary outcome measures (3)
- 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.]
- 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).]
- Safety of [68Ga]Ga-PN-EpC1 PET/CT Imaging [Time frame: Within 72 hours post-injection of [68Ga]Ga-PN-EpC1.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07400263 · 2025PHB625