Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Magnetic Resonance guided Focused ultrasound (MRgFUS)
- Conditions
- Glioma, Malignant
- Sponsor
- InSightec
- Enrollment
- 3
- Locations
- 4
- Primary Endpoint
- Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging
- Status
- Completed
- Last Updated
- 16 days ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is eligible for adjuvant TMZ treatment.
- •Men or women age between 18 and 80 years, inclusive.
- •Able and willing to give informed consent.
- •Grade IV glioma (GBM) confirmed Subjects
- •Karnofsky rating 70-
- •Able to communicate during the Exablate BBBD procedure.
- •Life expectancy of at least 3 months.
Exclusion Criteria
- •Evidence of acute intracranial hemorrhage.
- •The subject presents with severe symptoms and signs of increased intracranial pressure
- •Patients with cerebellar or brainstem tumors.
- •Patients with positive HIV status
- •Patients with brain tumors containing 1p/19q chromosomal co-deletion
- •Patient receiving bevacizumab (Avastin) therapy
- •Patients undergoing other concurrent therapies
- •Cardiac disease or unstable hemodynamics
- •Severe hypertension
- •Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment
Arms & Interventions
Focused Ultrasound (FUS) BBB Disruption
The Exablate Model 4000 Type 2.0 system is intended for use as a tool to induce localized and temporary blood-brain barrier disruption in patients with glioblastoma undergoing standard of care chemotherapy.
Intervention: Magnetic Resonance guided Focused ultrasound (MRgFUS)
Outcomes
Primary Outcomes
Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging
Time Frame: At the time of each ExAblate MRgFUS procedure]
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.
Device and procedure related adverse events
Time Frame: Throughout the study, approximately 12 months.
The number and severity of device and BBB disruption procedure related adverse events will be evaluated and classified according to the CTCAE