Focused Ultrasound Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: 1. Age between 18 and 85 years, inclusive. 2. Able and willing to provide written informed consent. 3. Diagnosis of Glioblastoma by histology or molecular markers based on WHO 2021 classification. 4. Previously undergone a maximal safe surgical resection and completed concurrent, standard-of-care RT and TMZ without any complications and deemed eligible for the maintenance phase of TMZ treatment. 5. Tumor or tumor resection cavity is clearly defined on screening MRI scans. 6. Karnofsky Performance Score rating 70-100. 7. American Society of Anesthesiologists (ASA) physical status score of 1-3. 8. Life expectancy of at least 3 months and able to attend all study visits. Exclusion Criteria: 1. Patients presenting with the following imaging characteristics: i. Following steroid treatment, brain edema and/or mass effect that causes midline shift or shift in wall of the third ventricle of more than 10 mm. ii. Evidence of recent (less than 2 weeks) intracranial hemorrhage.