Condition: GBM · Glioblastoma Multiforme (GBM) · Glioblastoma Multiforme of Brain · Sponsor: Sunnybrook Health Sciences Centre
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.
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.
| Sunnybrook Health Sciences Centre | Toronto, Ontario, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07179328