A Study to Evaluate the Safety and Feasibility of Exablate Model 4000 Type-2 to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) in Patients With Suspected Infiltrating Glioma in the Setting of Planned Surgical Interventions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glioma
- Sponsor
- InSightec
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Device and procedure related adverse events
- Status
- Suspended
- Last Updated
- 3 years ago
Overview
Brief Summary
This study is designed to assess the safety and feasibility of using the ExAblate, Type 2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma. The ExAblate Model 4000 Type-2 is intended for use as a tool to disrupt the BBB.
Detailed Description
This study is a prospective, single-arm, non-randomized, open-label feasibility study to evaluate the safety of focal BBBD using the ExAblate® 4000 Type 2 system. Up to 15 subjects with suspected infiltrating glioma who are scheduled to undergo brain tumor resection may be recruited for the study. Only patients that have a non-enhancing tumor components in a non-eloquent region of the planned standard-of-care resection volume will be eligible. Up to 4 centers may participate in this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or Female between 21-85 years of age
- •Able and willing to give informed consent
- •Subjects with suspected infiltrating glioma on pre-operative brain imaging scans including non-enhancing MRI tumor components in non-eloquent regions that are within the planned surgical resection volume
- •Surgical area targeted for ExAblate treatment (i.e. prescribed Region of Treatment) ≤30 cm3; planned surgical resection volume may exceed the targeted treatment volume
- •Karnofsky Performance Score 70-100
- •Able to communicate sensations during the ExAblate® BBBD procedure
Exclusion Criteria
- •MRI or clinical findings of:
- •Active or chronic infection(s) or inflammatory processes
- •Acute or chronic hemorrhages, specifically any lobar microbleeds, and no siderosis, amyloid angiopathy, or macrohemorrhages
- •Intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis
- •Evidence of tumor-related calcification, cyst, or hemorrhage
- •Midline shift of \>10mm or evidence of subfalcine, uncal, or tonsillar herniation on pre-operative imaging
- •More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
- •Clips, shunts, or any metallic implanted objects in the skull or the brain or the presence of unknown MR unsafe devices anywhere within the body
- •Significant cardiac disease or unstable hemodynamic status
- •Uncontrolled hypertension (systolic \> 150 and diastolic BP \> 100 on medication)
Outcomes
Primary Outcomes
Device and procedure related adverse events
Time Frame: At the time of the ExAblate MRgFUS procedure
The number and severity of device and BBBD procedure related adverse events will be evaluated.
Secondary Outcomes
- Feasibility of BBB disruption(At the time of the ExAblate MRgFUS procedure and 24 hours post-procedure)