Actively Recruiting
ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Craniopharyngioma Patients
Led by Deling Li · Updated on 2025-09-17
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Deling Li
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating 68Ga-MY6349, an immune-PET tracer that targets the trophoblast cell surface antigen 2 (Trop2), for its ability to noninvasively diagnose craniopharyngioma, a type of brain tumor. Trop2 is a protein involved in tumor growth and is often overexpressed in craniopharyngioma and other epithelial tumors. This study compares the diagnostic accuracy of 68Ga-MY6349 PET imaging with standard MRI and examines the correlation between PET scan results and Trop2 levels in tumor tissue. Participants will receive a single intravenous injection of 68Ga-MY6349 followed by PET/CT imaging before their scheduled craniopharyngioma surgery. The study evaluates the maximum standardized uptake value (SUVmax) from the PET images to quantify tumor uptake. After surgery, tumor tissue samples will be analyzed to confirm Trop2 expression and compare it with imaging findings. During the study, participants undergo PET/CT and standard MRI scans before surgery and have their tumor tissue tested after surgery. The primary outcome is the SUVmax from the PET scans, measured within one week after imaging. Secondary outcomes include assessing how well PET/CT with 68Ga-MY6349 can noninvasively evaluate Trop2 expression, measured within two weeks after surgery. Participants are monitored for safety and diagnostic accuracy throughout the study, which lasts from the initial imaging to postoperative assessments.
CONDITIONS
Brief Title
ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Craniopharyngioma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be able to provide written informed consent
- Have a radiologically presumed and/or histologically confirmed craniopharyngioma scheduled for surgical removal
- Have adequate clinical condition with Karnofsky performance status of 70 or higher
You will not qualify if you...
- Have major central nervous system disorders other than craniopharyngioma
- Have severe liver or kidney dysfunction
- Have a history of severe allergy or hypersensitivity to intravenous radiographic contrast agents
- Experience claustrophobia that prevents PET/CT or MRI exams
- Are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Within 1 week
Participants receive a single intravenous injection of 68Ga-MY6349 and undergo PET/CT imaging to assess Trop2 expression in craniopharyngioma prior to surgery.
1 visit (in-person)
Duration - Not specified
Participants undergo surgical removal of the craniopharyngioma tumor.
Duration - Within 2 weeks after surgery
Participants are monitored after surgery to evaluate PET/CT imaging feasibility and correlate imaging results with pathological specimens.
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
D
Deling Li, MD
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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