Clinical Trial

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

Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07179328
Lead Sponsor Sunnybrook Health Sciences Centre
Conditions GBM, Glioblastoma Multiforme (GBM), Glioblastoma Multiforme of Brain, Glioblastoma Multiforme Glioma, HGG, Glioma, Brain Tumor Adult, Brain Tumor, Primary
Enrollment 10 participants
Start Date 2025-06-04
Primary Completion 2027-07 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2025-09-17