Actively Recruiting
A Prospective Clinical Study of an EpCAM-Targeted Radiotracer for Molecular Imaging of Epithelial Tumors
Led by Peking University People's Hospital · Updated on 2026-03-30
30
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the imaging performance and safety of an EpCAM-targeted radiotracer called [68Ga]Ga-PN-EpC1 in patients with epithelial tumors. The study aims to determine how well this PET/CT imaging tracer detects EpCAM-positive tumor lesions, how tracer uptake relates to EpCAM levels in tumor tissue, and whether the radiotracer is safe and well tolerated. Participants will receive a single intravenous dose of the [68Ga]Ga-PN-EpC1 radiotracer at 0.05-0.1 mCi/kg, followed by whole-body PET/CT imaging according to the study protocol. Some participants may have additional dynamic or delayed imaging. The imaging is done prior to tumor biopsy or surgical removal, and findings will be compared with tissue analysis and standard imaging. During the study, participants will undergo PET/CT scans and then have tumor biopsies or surgery within two months for histopathological confirmation. Safety is monitored by tracking any adverse events up to 72 hours after radiotracer injection. The main measure is the sensitivity of the PET/CT in detecting lesions, with secondary measures including specificity, accuracy, correlation with EpCAM expression, and overall safety. This trial runs until December 2028.
CONDITIONS
Brief Title
Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with diagnosed or suspected tumors scheduled for biopsy or surgery within 2 months
- Age over 18 years, any gender
- Adequate organ and bone marrow function as shown by lab tests
- Normal cardiac function
- Expected life expectancy of at least 12 weeks
- At least one measurable tumor lesion according to RECIST v1.1
- Clinician recommendation for PET/CT imaging for diagnosis or staging
- Negative pregnancy test for women of childbearing potential within 7 days before imaging
- Agreement to use effective contraception during and for 3 months after the study
- Voluntary participation with informed consent
You will not qualify if you...
- Severe abnormalities in liver, kidney, or blood function
- History of allergic diseases
- Planning pregnancy during the study period
- Pregnant or breastfeeding women
- Inability to lie flat on back for at least 30 minutes
- Claustrophobia or psychiatric disorders affecting compliance
- Any condition increasing risk or interfering with study evaluation as judged by investigators
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessments including lab tests and pregnancy test if applicable
Duration - Single day
Participants receive a single intravenous administration of the EpCAM-targeted radiotracer [68Ga]Ga-PN-EpC1 followed by PET/CT imaging to detect epithelial tumors.
1 visit (in-person) for radiotracer injection and PET/CT imaging, with possible additional imaging in selected participants
Duration - Up to 2 months
Participants are monitored for safety and correlation of imaging results with biopsy or surgical specimen analyses over the following 2 months.
Follow-up assessments within 72 hours post-injection and monitoring during biopsy or surgery scheduled within 2 months
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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