Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption (NCT03551249) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption
United States20 participantsStarted 2019-03-26
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 70-100.
✓. 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:
✕. The sonication pathway to the tumor involves:
✕. 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.
What they're measuring
1
Device and procedure related adverse events
Timeframe: Throughout the study, approximately 12 months.