NCT07179328

Focused Ultrasound Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy

Assessment of Safety and Feasibility of Focused Ultrasound Next Generational Dome Helmet Mediated Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety and feasibility of focused ultrasound (FUS)-mediated blood-brain barrier (BBB) disruption using the Next Generation Dome Helmet (NGDH) in adults with glioblastoma (GBM) undergoing the maintenance phase of the standard "Stupp protocol". Participants will: * Undergo repeated FUS BBB disruption treatments during the maintenance phase of temozolomide (TMZ) chemotherapy. * Receive intravenous ultrasound contrast (DEFINITY®) prior to each FUS session to facilitate targeted BBB disruption. * Undergo serial MRI scans and clinical assessments to evaluate safety and the extent of BBB opening. * Provide blood samples (and tumor tissue if available) for biomarker analysis related to BBB permeability, tumor presence, and treatment response. * Be followed for progression-free survival (PFS) and overall survival (OS) during routine neuro-oncology visits until end of life.

Detailed description

This is a Phase I, single-center, single-arm clinical trial. Approximately 10 participants are expected to be enrolled. The active therapy phase for participants will last approximately 6 to 8 months. Information about each participant's condition will continue to be collected for as long as possible to evaluate the effects of the therapy.

Conditions

• GBM
• Glioblastoma Multiforme (GBM)
• Glioblastoma Multiforme of Brain
• Glioblastoma Multiforme Glioma
• HGG
• Glioma
• Brain Tumor Adult
• Brain Tumor, Primary

Interventions

Type	Name	Description
DEVICE	Focused Ultrasound Next Generation Dome Helmet	The Next Generation Dome Helmet (FUS NG) is a non-invasive, MRI-guided focused ultrasound system developed at Sunnybrook Research Institute. It is used to disrupt the blood-brain barrier (BBB) in patients with glioblastoma during the maintenance phase of temozolomide (TMZ) therapy. The device allows targeted BBB opening using a fixed transducer array and intravenous DEFINITY® contrast.
DRUG	Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension	DEFINITY® Perflutren Injectable Microbubbles is an ultrasound contrast imaging agent that will be used for blood brain barrier opening during focused ultrasound. These microbubbles will be injected during the focused ultrasound procedure.

Timeline

• Start date: 2025-06-04
• Primary completion: 2027-07-01
• Completion: 2027-11-01
• First posted: 2025-09-17
• Last updated: 2025-09-17

Locations

1 site across 1 country: Canada