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
- Not specified
- Conditions
- Glioma
- Sponsor
- InSightec
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- Device and procedure related adverse events
- Status
- Completed
- Last Updated
- last month
Overview
Brief Summary
The purpose of this study is to evaluate the safety of the ExAblate Model 4000 Type 2 used as a tool to disrupt the BBB (blood brain barrier) in patients with high grade glioma undergoing standard of care therapy.
Detailed Description
This is a prospective, multi-center, single-arm study to establish the safety and feasibility of BBB (blood brain barrier) disruption along the periphery of tumor resection cavity using the ExAblate Neuro Model 4000 Type 2 (220 kHz) system. For this study, patients will be eligible to enroll in the study prior to beginning the planned adjuvant TMZ chemotherapy phase of treatment. Of note, only patients who are deemed eligible for adjuvant TMZ will be eligible for enrollment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is eligible for adjuvant temozolomide (TMZ) treatment based on the current standard of care.
- •Men or women age between 18 and 80 years, inclusive.
- •Able and willing to give informed consent.
- •Grade IV glioma (GBM)
- •Combined radiation/TMZ treatment is completed based on the prescribed standard of care regimen.
- •Karnofsky rating 70-
- •Able to communicate during the ExAblate BBBD (Blood Brain Barrier Disruption) procedure.
- •Able to attend all study visits (i.e., life expectancy of at least 3 months).
Exclusion Criteria
- •Patients presenting with the following imaging characteristics:
- •i. Evidence of acute intracranial hemorrhage.
- •The sonication pathway to the tumor involves:
- •i. Extensive scalp sores. ii. Clips or other metallic implanted objects in the skull or the brain (brain implants)
- •The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).
- •Patients with cerebellar or brainstem tumors.
- •Patients with positive HIV status.
- •Significant depression not adequately controlled with medication and at potential risk of suicide.
- •Patient receiving bevacizumab (Avastin) therapy.
- •Patients receiving treatment with corticosteroid doses greater than dexamethasone 24 mg daily (or equivalent).
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging(At the time of each ExAblate MRgFUS procedure)