NCT04440358

Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM

Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption (BBBD) With Microbubbles for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (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 and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.

Detailed description

This is a Phase 1/2, open-label, prospective, multi-center, single-arm study to establish the safety and feasibility of blood-brain-barrier disruption (BBBD) combined with intravenous carboplatin for the treatment of rGBM using the Exablate Neuro Model 4000 Type 2 system. Adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered for study enrollment. Eligible subjects will undergo up to 6 cycles of Exablate BBBD procedures in conjunction with carboplatin chemotherapy.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
DEVICE	Exablate BBBD	BBB opening via Exablate Neuro Type 2 system to deliver carboplatin
DRUG	Carboplatin	Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain

Timeline

• Start date: 2020-10-13
• Primary completion: 2023-11-30
• Completion: 2023-12-31
• First posted: 2020-06-19
• Last updated: 2026-01-20

Locations

3 sites across 3 countries: Canada, Italy, South Korea