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

Inclusion Criteria:

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

Exclusion Criteria:

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