RecruitingPhase 1NCT07179328

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


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

10 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using focused ultrasound to temporarily open the blood-brain barrier — the protective shield around the brain — can improve the delivery of chemotherapy to glioblastoma tumors. Standard chemotherapy often cannot cross this barrier effectively, limiting its ability to treat brain tumors. **You may be eligible if...** - You are between 18 and 85 years old - You have been diagnosed with glioblastoma (a type of brain cancer) confirmed by tissue analysis using WHO 2021 criteria - You have already completed the initial surgery plus concurrent radiation and temozolomide chemotherapy without complications - You are eligible to begin the maintenance phase of temozolomide chemotherapy - Your Karnofsky Performance Score is 70-100 (able to care for yourself and carry on normal activities) **You may NOT be eligible if...** - You have not yet completed the initial chemoradiotherapy phase - Your Karnofsky score is below 70 - You have conditions that make focused ultrasound or anesthesia unsafe (e.g., ASA score above the threshold) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFocused 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.

DRUGDefinity® 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.


Locations(1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT07179328


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