NCT03712293

ExAblate Blood-Brain Barrier Disruption for Glioblastoma in Patients Undergoing Standard Chemotherapy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of the ExAblate Model 4000 Type 2.0 used as a tool to disrupt the BBB in patients with Glioblastoma undergoing standard of care therapy.

Detailed description

This is a prospective, multisingle-center, single-arm study to establish the safety and feasibility of BBB disruption along the periphery of tumor resection cavity using the ExAblate Neuro Model 4000 Type 2.0 (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. This study will enroll up to 20 subjects.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DEVICE	BBB Disruption with Chemotherapy Arm	The ExAblate BBB disruption of targets associated with enhancing post-resection MRI imaging procedure will be performed with ExAblate 4000 type 2.0 system and will coincide with on one of three first days of each planned TMZ adjuvant therapy cycle as one procedure per cycle.

Timeline

• Start date: 2018-08-28
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2018-10-19
• Last updated: 2024-03-05

Locations

1 site across 1 country: South Korea