Study of Early Post-operative PET-MRI Using 18F-DOPA and Gadolinium to Detect Residual Glioblastoma and Assess Safety

What this Trial Is About

Researchers are evaluating the safety and feasibility of early post-operative brain PET-MRI imaging in adults who have undergone surgery for suspected glioblastoma. The study aims to validate specific nuclear imaging parameters to improve detection of residual tumor tissue compared to standard gadolinium-enhanced MRI. This prospective interventional diagnostic study will include 15 patients at a single site in France, focusing on imaging within 48 hours after surgery and monitoring for side effects related to the imaging procedures. Participants will undergo combined PET-MRI imaging using 18F-DOPA as the radiotracer and gadolinium-based contrast for MRI enhancement. The PET scan involves an intravenous injection of 18F-DOPA at 2 MBqkg with static brain acquisition starting immediately after injection. MRI sequences include diffusion, spectroscopy, perfusion, and angiography scans. Patients will be monitored for radiation exposure and any adverse events during and after imaging, with a total monitoring period of 24 hours post-procedure. During the study, participants receive a pre-surgical baseline evaluation including medical history, PET-MRI, and MRI scans within 30 days to 2 days before surgery. After surgery, informed consent is obtained, followed by post-operative PET-MRI imaging and monitoring in the nuclear medicine department. Dosimetry measurements occur over 24 hours to assess radiation exposure. Safety assessments include observation for hypersensitivity or side effects related to gadolinium or 18F-DOPA. The study lasts approximately 24 hours per patient, with follow-up managed by the usual neurosurgical care team.

Assessment of Early Post-operative Nuclear Imaging in Neurosurgery: a Safety and Feasibility Study in Patients Operated for Glioblastoma