Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Location status: Recruiting
NCT Number: NCT07400263
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100044, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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).
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.
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.
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.
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).
Peking University People's Hospital
Other
A Prospective Clinical Study of an EpCAM-Targeted Radiotracer for Molecular Imaging of Epithelial Tumors
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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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