Safety and Feasibility Study of Focused Ultrasound Using the Next Generation Dome Helmet to Open the Blood-Brain Barrier in Adults with Glioblastoma Receiving Standard Chemotherapy

What this Trial Is About

Researchers are evaluating the safety and feasibility of using focused ultrasound FUS with the Next Generation Dome Helmet NGDH to temporarily open the blood-brain barrier BBB in adults with glioblastoma who are undergoing the maintenance phase of standard chemotherapy with temozolomide TMZ. This Phase I clinical trial is designed to study how this non-invasive device can assist in targeted drug delivery by disrupting the BBB, potentially improving treatment outcomes for this aggressive brain tumor. Participants in this single-arm study will receive up to six FUS BBB disruption sessions spaced 4 to 6 weeks apart while continuing their standard TMZ chemotherapy. Before each FUS session, they will receive an intravenous injection of DEFINITY ultrasound contrast agent to help open the BBB in a targeted way. MRI will guide each treatment and assess how much the BBB opens. Alongside these treatments, clinical evaluations and blood sampling will be done regularly to study the effects of BBB disruption. During the study, participants will undergo regular MRI scans and clinical assessments to monitor safety and the extent of BBB opening. Blood samples and, if available, tumor tissue will be collected to analyze biomarkers related to treatment response. Safety evaluations will happen at baseline, then every 8 weeks during the first year and every 12 weeks in the second year, with participants also being followed for progression-free and overall survival at routine neuro-oncology visits until the end of life. The active treatment phase lasts about 6 to 8 months, with ongoing data collected as long as possible.

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