NCT03551249

Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption

Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier Disruption for the Treatment of High Grade Glioma in Patients Undergoing Standard Chemotherapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioma
• Glioblastoma

Interventions

Type	Name	Description
DEVICE	Focused ultrasound (FUS)	FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.

Timeline

• Start date: 2019-03-26
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2018-06-11
• Last updated: 2026-03-20

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study