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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
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.
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.
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.
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).
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.
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