Ga-68 PSMA-11 PET/CT Imaging to Detect Malignant Glioma Recurrence or Progression

What this Trial Is About

Researchers are studying the use of gallium-68 (Ga-68) PSMA-11 PET/CT imaging to help distinguish between tumor recurrence or progression and treatment effects in patients with glioma, specifically those with WHO grade III or IV infiltrating gliomas. This is important because after initial treatment, standard imaging may not clearly differentiate between active tumor and treatment-related changes, often requiring surgery for a definitive diagnosis. This phase 2 study aims to assess the feasibility and safety of this imaging technique and explore its diagnostic value beyond standard MRI scans. Participants receive an intravenous injection of Ga-68 PSMA-11, a radioactive imaging agent that binds to tumor blood vessels, followed by a combined PET/CT scan approximately 50 to 100 minutes later, lasting about one hour. The PET scanner detects the radioactive tracer's location, while the CT scanner provides detailed structural images. Researchers will compare the PSMA-11 uptake seen on PET with biopsy results and MRI findings to determine its accuracy in identifying tumor activity versus treatment effects. During the study, participants will undergo the PET/CT scan after injection of the imaging agent. Researchers will monitor for any adverse effects up to 24 hours post-injection and assess tolerability over 60 days. Data will be collected from clinical MRI scans and tissue samples for correlation with PET findings. The study will evaluate imaging results using visual and quantitative measures to identify optimal thresholds distinguishing tumor progression from treatment effect, enhancing diagnosis and patient care.

An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression in Patients With Glioma