Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption in GBM Patients

The primary objective is to evaluate the safety and feasibility of BBB disruption using the Exablate Type 2.0 system in adult patients with glioblastoma (GBM) undergoing adjuvant TMZ chemotherapy, which occurs following maximal safe surgical resection and completion of the initial concurrent radiation-chemotherapy in accordance with the current standard of care

Inclusion criteria

• Patient is eligible for adjuvant TMZ treatment.
• Men or women age between 18 and 80 years, inclusive.
• Able and willing to give informed consent.
• Grade IV glioma (GBM) confirmed Subjects
• Karnofsky rating 70-100.
• Able to communicate during the Exablate BBBD procedure.
• Life expectancy of at least 3 months.

Exclusion criteria

• Evidence of acute intracranial hemorrhage.
• The subject presents with severe symptoms and signs of increased intracranial pressure
• Patients with cerebellar or brainstem tumors.
• Patients with positive HIV status
• Patients with brain tumors containing 1p/19q chromosomal co-deletion
• Patient receiving bevacizumab (Avastin) therapy
• Patients undergoing other concurrent therapies
• Cardiac disease or unstable hemodynamics
• Severe hypertension
• Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment
• History of a bleeding disorder and/or coagulopathy
• Known sensitivity to gadolinium-based contrast agents
• Known sensitivity to ultrasound contrast agent
• Severely impaired renal function
• Subjects with significant liver dysfunction