← Eichor
Study identifier: NCT07179328 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: GBM · Glioblastoma Multiforme (GBM) · Glioblastoma Multiforme of Brain  ·  Sponsor: Sunnybrook Health Sciences Centre

PhasePhase 1
Planned participants10
Who can joinAll sexes, 18 Years to 85 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Nir Lipsman, MD, PhD, FRCSC  ·  (416)-480-6954  ·  Nir.Lipsman@sunnybrook.ca

Maheleth Llinas  ·  416 480-6100  ·  maheleth.llinas@sunnybrook.ca

Always discuss trial participation with your own doctor first.

Locations (1)

Sunnybrook Health Sciences CentreToronto, Ontario, CanadaRecruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT07179328