NCT03616860

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

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: 14 (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 blood-brain barrier (BBB) disruption in adult patients with a first presentation of a glioblastoma (GBM) following a maximal safe surgical resection and standard chemo-radiation with temozolomide (TMZ) protocol and ready for the maintenance phase of the Stupp protocol with TMZ.

Detailed description

This is a prospective, single center, single-arm study to establish the safety, feasibility, and effectiveness of BBB disruption along the periphery of the tumor resection cavity using the ExAblate Neuro Model 4000 Type 2 (220 kHz) system and DEFINITY ultrasound contrast in patients with GBM. Adult patients with a first time diagnosis of GBM, whom have undergone maximal safe surgical resection and have safely completed the initial phase of concurrent chemo-radiation therapy, will be recruited for this study. Twenty patients will undergo up to 6 treatments with FUS coincident with their standard TMZ cycles.

Conditions

• Glioblastoma

Interventions

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

Timeline

• Start date: 2018-10-16
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2018-08-06
• Last updated: 2024-01-23

Locations

1 site across 1 country: Canada