Study to Evaluate Safety and Feasibility of Intratumoral Alpha Radiation Device for Treating Recurrent Glioblastoma

What this Trial Is About

Researchers are evaluating a new approach using an intratumoral diffusing alpha radiation emitter device called DaRT for treating recurrent Glioblastoma, a type of brain cancer. This prospective, open-label, single-arm, multi-center interventional study aims to assess the feasibility and safety of placing DaRT seeds directly into the tumor. The study plans to enroll 10 participants with recurrent Glioblastoma who meet specific criteria. Participants will undergo a procedure where DaRT seeds impregnated with Ra-224 are inserted into the tumor using a specialized applicator. After the procedure, participants will return for follow-up visits every two months for up to 12 months to monitor their condition. Survival follow-up will continue through phone calls every 2 to 3 months until new anti-cancer treatment starts, the disease progresses, or the participant passes away. During the study, researchers will assess the placement feasibility of DaRT seeds and monitor adverse events over 12 months. Additional evaluations include toxicity profiles within four weeks after radiotherapy, radiographic tumor control starting one month after surgery, rates of pseudo-progression at the first post-implant scan, and overall survival up to 12 months post-implant. Participants will undergo regular MRI scans, blood tests, and clinical assessments to track safety and treatment effects throughout the trial.

Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Glioblastoma