Noninvasive PET Imaging Using 68Ga-MY6349 to Detect Trop2 in Patients with Craniopharyngioma Scheduled for Surgery

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 PETCT 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 PETCT 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 PETCT 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.

ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Craniopharyngioma Patients