The purpose of this study is to evaluate the safety of the Exablate Model 4000 Type 2.0 used as a tool to disrupt the BBB in patients with high grade glioma undergoing standard of care therapy.
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
Study Type
OBSERVATIONAL
Enrollment
3
FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.
Fondazione IRCCS Neurologico Carlo Besta
Milan, Italy
CINAC-Hospital HM Puerta del Sur
Móstoles, Madrid, Spain
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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