Study of Local Targeted Alpha Therapy Using 225AcAc-DOTA-SP for Adults with Recurrent High-Grade Glioma WHO G3-G4

What this Trial Is About

Brain tumors, including gliomas, are serious conditions that make up a significant portion of central nervous system tumors and cause a notable number of cancer-related deaths. Malignant gliomas particularly have a low survival rate despite standard treatments like surgery, radiotherapy, and chemotherapy. This research aims to evaluate the safety and effectiveness of a new local targeted therapy using the alpha-emitting neuropeptide 225AcAc-DOTA-SP in patients with recurrent high-grade gliomas WHO grade 3 and 4 after initial therapy. The study is interventional and led by the Medical University of Warsaw with contributions from neurosurgery and nuclear medicine experts. Participants will receive up to six cycles of 225AcAc-DOTA-SP administered directly into the tumor or resection cavity through a catheter placed during a surgical procedure. Before treatment, imaging using PETCT with specific tracers will guide catheter placement and assess distribution. The therapy involves a slow infusion of the radiopharmaceutical combined with supportive intravenous medications and brain imaging to monitor delivery. Hospitalization for several days is required for catheter placement and treatment administration, with close monitoring for side effects such as seizures. Throughout the study, participants will undergo regular blood and urine tests, neurological assessments, MRI scans every two months, and follow-up visits that may include telemedicine for up to 18 months or longer. The main outcomes measured are clinical and radiological progression of the glioma, with overall survival and progression-free survival as key endpoints. Biological samples will also be collected during surgery for further analysis. Patient data will be anonymized and securely stored for research purposes. The study is expected to last three years with ongoing monitoring of survival for participants alive at the end.

Local, Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) in Glioma (WHO G3-G4) Progression