Actively Recruiting
Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors
Led by Peking University People's Hospital · Updated on 2026-03-30
30
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 pathological biopsy or surgical treatment within 2 months
- Age over 18 years, any gender
- Adequate organ and bone marrow function as defined by laboratory tests (WBC \u22654.0x10^9/L or ANC \u22651.5x10^9/L; PLT \u2265100x10^9/L; Hemoglobin \u226590 g/L; Total bilirubin \u22641.5x ULN; ALT and AST \u22642.5x ULN or \u22645x ULN if liver metastases present; BUN \u22641.5x ULN; Serum Creatinine \u22641.5x ULN)
- Normal cardiac function
- Expected life expectancy of at least 12 weeks
- Presence of at least one measurable target lesion per RECIST v1.1
- Recommended by clinicians for PET/CT examination for tumor diagnosis and staging
- Women of childbearing potential must have a negative pregnancy test within 7 days before examination
- Male and female patients of reproductive age must agree to use effective contraception during the study and for at least 3 months after examination
- Voluntary participation with full understanding and signed informed consent
You will not qualify if you...
- Severe laboratory abnormalities including significant liver or kidney impairment or severe blood disorders
- History of allergic diseases
- Planning pregnancy during the study period
- Pregnant or breastfeeding women
- Inability to remain in a supine position for at least 30 minutes
- Claustrophobia or psychiatric disorders interfering with study compliance
- Any other condition judged by the investigator to increase risk or interfere with study evaluation
AI-Screening
AI-Powered Screening
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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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