The purpose of this study is to evaluate the safety and effectiveness of using the Exablate Type 2 system using microbubble resonators (Exablate Test Arm) to disrupt the Blood-Brain Barrier for the purpose of temporarily transforming, and thereby 'marking', regions of infiltrating gliomas prior to planned surgical resection, for the purpose of improving tumor visualization during the surgery to achieve a greater proportion of subjects who receive a Gross Total Resection (GTR) per plan compared to those not undergoing a BBBD procedure prior to resection (Control Arm).
After being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized in a 2:1 ratio to Exablate Test Arm and to Control Arm, respectively. The following assessments will occur: 1. Pre-surgical planning and Post-surgical visit MRI exams with and without contrast will be collected for evaluation by the study core lab; Any return to surgery for additional resection will be captured 2. All subjects will be seen at \~Week 2, and \~4-Weeks post resection for physical and neurological exams and to assess for complications or adverse events. These visits should coincide with standard (Neuro-oncology) care following resection. 3. Long-term outcomes will be collected during standard of care Neuro-oncology care follow-up visits for up to 2 years post resection; standard of care MRIs and RANO assessments will be collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Blood brain barrier disruption using ExAblate Type 2 device using microbubble resonators
University of Maryland
Baltimore, Maryland, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Overall safety of the Exablate BBBD procedure itself as measured through the collection of adverse events
Safety of the Exablate BBBD procedure will be evaluated by patient examination and post-procedure MRI exams assessing changes in the treated region. Adverse events will be reported by the Investigator and monitored in both treatment arms.
Time frame: Approximately 2 months
Effectiveness of BBBD as determined by the proportion of subjects in whom a GTR is acheived
The proportion of subjects in whom a gross total resection (actual versus planned) is achieved as measured on post-operative imaging compared to pre-resection imaging
Time frame: MRI 72 hours post resection
Confirmation of accuracy of Exablate BBBD targeting
Confirmation that new BBBD by contrast enhancement in a previously non-enhancing area overlies the intended target for BBBD. (ExAblate arm only)
Time frame: MRI immediately after the ExAblate procedure
Return Rate for Second Surgery for Completion of Resection
Comparison of the Return Rate between the two treatment arms.
Time frame: Approximately 2 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.