Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors
ConditionEpithelial Tumors, Malignant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
[68Ga]Ga-PN-EpC1 PET/CT
Diagnostic testParticipants 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: EpCAM PETExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From PET/CT imaging to histopathological confirmation within 2 months.Secondary outcomes
1
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.
Time frame
From PET/CT imaging to histopathological confirmation within 2 months.2
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).
Time frame
From PET/CT imaging to IHC analysis of biopsy or surgical specimens (within 2 months).3
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.
Time frame
Within 72 hours post-injection of [68Ga]Ga-PN-EpC1.Other outcomes
1
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.
Time frame
From initial imaging assessment to the end of follow-up at 2 years.2
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.
Time frame
From PET/CT imaging to the end of follow-up at 2 years.3
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).
Time frame
From PET/CT imaging to the end of follow-up at 2 years.Sponsors and contacts
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Source ClinicalTrials.gov