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

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

Trial Details

NCT ID
NCT07179328
Phase
PHASE1
Sponsor
Sunnybrook Health Sciences Centre
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Focused Ultrasound Next Generation Dome Helmet
  • Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
Locations (sample)
  • Toronto, Ontario, Canada|43.70643,-79.39864

Key Eligibility Criteria

  • Age between 18 and 85 years, inclusive.
  • Able and willing to provide written informed consent.
  • Diagnosis of Glioblastoma by histology or molecular markers based on WHO 2021 classification.
  • Previously undergone a maximal safe surgical resection and completed concurrent, standard-of-care RT and TMZ without any complications and deemed e…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Brain Cancer Trials on Trialify →