The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.
This is a Phase 1/2, open-label, prospective, multi-center, single-arm study to establish the safety and feasibility of blood-brain-barrier disruption (BBBD) combined with intravenous carboplatin for the treatment of rGBM using the Exablate Neuro Model 4000 Type 2 system. Adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered for study enrollment. Eligible subjects will undergo up to 6 cycles of Exablate BBBD procedures in conjunction with carboplatin chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
BBB opening via Exablate Neuro Type 2 system to deliver carboplatin
Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Fondazione IRCCS Neurologico Carlo Besta
Milan, Italy
Yonsei University Medical Center
Seoul, South Korea
Occurrence of Adverse Events
All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria
Time frame: Through study completion, an average of 12 months
Contrast intensity on MR imaging
BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging
Time frame: Immediately after Exablate BBBD procedure
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