MR-guided focused ultrasound (MRgFUS) developer InSightec has received approval from the U.S. Food and Drug Administration (FDA) to initiate a study to evaluate the safety and feasibility of its Exablate Neuro device for disrupting the blood-brain barrier in patients with glioblastoma.
A research team will inject a commonly used sonographic microbubble solution into the bloodstream of patients with a malignant brain tumor. Ultrasound waves will oscillate the microbubbles, causing temporary disruption of the blood-brain barrier. The trial will include up to 15 subjects with suspected glioblastoma who are scheduled to undergo tumor resection.
Leading the study is Dr. Graeme Woodworth, an associate professor of neurosurgery and director of the Brain Tumor Treatment & Research Center at the University of Maryland School of Medicine and an attending neurosurgeon at the University of Maryland Medical Center.
