The purpose of this study is to evaluate the safety of the ExAblate Model 4000 Type 2 used as a tool to disrupt the BBB (blood brain barrier) in patients with high grade glioma undergoing standard of care therapy.
This is a prospective, multi-center, single-arm study to establish the safety and feasibility of BBB (blood brain barrier) disruption along the periphery of tumor resection cavity using the ExAblate Neuro Model 4000 Type 2 (220 kHz) system. For this study, patients will be eligible to enroll in the study prior to beginning the planned adjuvant TMZ chemotherapy phase of treatment. Of note, only patients who are deemed eligible for adjuvant TMZ will be eligible for enrollment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.
University of Maryland
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Virginia
Charlottesville, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Device and procedure related adverse events
The number and severity of device and BBB disruption procedure related adverse events will be evaluated and classified according to the CTCAE
Time frame: Throughout the study, approximately 12 months.
Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging
The repeatability of BBB disruption will be evaluated at each of the 6 procedures and will be evaluated through assessment of post-procedure contrast-enhanced MR imaging.
Time frame: At the time of each ExAblate MRgFUS procedure
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