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 (Jun 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
Treatments studied
Other
Cancer type
Glioblastoma
Performance status
KARNOFSKY 70–100
Demographics
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.
Frequently asked questions
Is NCT07179328 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, radiation therapy, bevacizumab disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 85 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages