NCT05383872

Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors

A Pivotal Study to Evaluate the Safety and Effectiveness of Exablate Model 4000 Using Microbubble Resonators to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (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 efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for liquid biopsy in subjects with suspected Glioblastoma brain tumors

Detailed description

This is a prospective, multi-center, pivotal clinical trial to evaluate the safety and efficacy of targeted blood brain barrier disruption using Exablate Model 4000 Type 2 for liquid biopsy in subjects with suspected Glioblastoma brain tumors. The study will be conducted at up to 25 centers in the US.

Conditions

• Glioblastoma
• Glioma
• Liquid Biopsy

Interventions

Type	Name	Description
DEVICE	Focused Ultrasound (Exablate Model 4000)	BBB opening via Exablate Type 2 system with microbubble resonators and drawing blood before and after opening

Timeline

• Start date: 2022-08-08
• Primary completion: 2025-02-21
• Completion: 2025-03-05
• First posted: 2022-05-20
• Last updated: 2025-07-28

Locations

17 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study