OncoMatch/Clinical Trials/NCT07179328
Focused Ultrasound Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy
Is NCT07179328 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Focused Ultrasound Next Generation Dome Helmet and Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension for gbm.
Treatment: Focused Ultrasound Next Generation Dome Helmet · Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Performance status
KARNOFSKY 70–100
Prior therapy
Must have received: surgical resection
Previously undergone a maximal safe surgical resection
Must have received: radiation therapy — concurrent, standard-of-care
completed concurrent, standard-of-care RT
Must have received: temozolomide (temozolomide) — concurrent, standard-of-care
completed concurrent, standard-of-care ... TMZ
Cannot have received: chemotherapy
Exception: standard concurrent TMZ allowed
Previous full course of chemotherapy for GBM (at the discretion of investigator)
Cannot have received: radiation therapy
Exception: standard concurrent RT allowed
Previous radiotherapy
Cannot have received: bevacizumab (bevacizumab)
Patient receiving bevacizumab (Avastin) therapy
Cannot have received: chemotherapy wafer
Patients undergoing other concurrent therapies such as chemotherapy wafers
Cannot have received: immunotoxin
immunotoxins delivered by convection-enhanced delivery
Cannot have received: gene therapy
regionally administered gene and viral therapies
Cannot have received: immunotherapy
immunotherapies
Cannot have received: brachytherapy
focal irradiation with brachytherapy
Cannot have received: stereotactic radiosurgery
stereotactic radiosurgery
Cannot have received: laser interstitial thermotherapy
laser interstitial thermotherapy
Lab requirements
Blood counts
Abnormal level of platelets (< 100,000) or INR > 1.3 [excluded]
Kidney function
Severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2 and/or on dialysis [excluded]
Cardiac function
Cardiac disease or unstable hemodynamics including: documented myocardial infarction within six months, unstable angina, congestive heart failure, LVEF <50%, history of hemodynamically unstable arrhythmia, cardiac pacemaker
Cardiac disease or unstable hemodynamics including: documented myocardial infarction within six months of enrollment. Unstable angina on medication. Congestive heart failure. Left ventricular ejection fraction <50%. History of a hemodynamically unstable cardiac arrhythmia. Cardiac pacemaker. Abnormal level of platelets (< 100,000) or INR > 1.3. Severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2 and/or on dialysis.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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