NCT07179328View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

June 4, 2025

Primary Completion Date

July 31, 2027

Study Completion Date

November 30, 2027

Conditions
GBMGlioblastoma Multiforme (GBM)Glioblastoma Multiforme of BrainGlioblastoma Multiforme GliomaHGGGliomaBrain Tumor AdultBrain Tumor, Primary
Interventions
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.

Trial Locations (1)

M4N 3M5

RECRUITING

Sunnybrook Health Sciences Centre, Toronto

All Listed Sponsors
lead

Sunnybrook Health Sciences Centre

OTHER

NCT07179328 - Focused Ultrasound Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy | Biotech Hunter | Biotech Hunter