The FDA has approved an Investigational Device Exemption (IDE) to evaluate the NeuroBlate System in patients newly diagnosed with glioblastoma multiforme (GBM). With this approval, the Feasibility Study on Laser Interstitial Thermal Ablation for the Treatment of Newly Diagnosed GBM (FLAG), an open-label, prospective study, will be conducted in five sites in the U.S.
The NeuroBlate System, a type of MRI-guided laser interstitial thermal therapy, is used by surgeons to destroy and coagulate soft tissue lesions in the brain. Previously, an IDE approved study was conducted to evaluate the NeuroBlate System in patients with recurrent GBM.
FLAG is designed to characterize the safety, feasibility, and effectiveness of the NeuroBlate System in combination with standard of care radiation and chemotherapy in patients with newly diagnosed GBM.
The study will enroll participants for whom a complete surgical resection is unsafe due to location, shape or size of the tumor. Overall survival, progression-free survival, patient quality of life, and healthcare utilization will be assessed during the trial in 30 patients followed for up to 12 months after the procedure and subsequent radiation and chemotherapy.