The purpose of this study is to evaluate the safety of blood-brain barrier (BBB) disruption in adult patients with a first presentation of a glioblastoma (GBM) following a maximal safe surgical resection and standard chemo-radiation with temozolomide (TMZ) protocol and ready for the maintenance phase of the Stupp protocol with TMZ.
This is a prospective, single center, single-arm study to establish the safety, feasibility, and effectiveness of BBB disruption along the periphery of the tumor resection cavity using the ExAblate Neuro Model 4000 Type 2 (220 kHz) system and DEFINITY ultrasound contrast in patients with GBM. Adult patients with a first time diagnosis of GBM, whom have undergone maximal safe surgical resection and have safely completed the initial phase of concurrent chemo-radiation therapy, will be recruited for this study. Twenty patients will undergo up to 6 treatments with FUS coincident with their standard TMZ cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
FUS BBB disruption involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
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 (coincident with standard of care chemotherapy) and will be evaluated through assessment of post-procedure contrast enhanced MR imaging.
Time frame: Immediately after each FUS BBB disruption procedure
Effectiveness of BBB disruption in the treated tumor region
Effectiveness will be assessed based on the MRI characteristics of the FUS treated tumor region as assessed by the modified Response Assessment in Neuro-Oncology Criteria (RANO) to establish GBM status
Time frame: at each standard of care neuro-oncology follow up visit until date of death from any cause, assessed up to 48 months
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