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Recently published results from a multi-center phase 1/2 trial suggest that MRI-guided microbubble focused-ultrasound (MB-FUS) may improve outcomes when added to standard chemotherapy for newly diagnosed high-grade glioma. The study enrolled 34 newly diagnosed high-grade glioma patients between 2018 and 2022 (pre-2021 WHO reclassifications). Most of the tumors were IDH-wildtype, with a mix of MGMT-methylated and unmethylated cases.
After surgery and standard chemoradiation, patients received monthly outpatient MB-FUS treatments given once at the start of each temozolomide cycle to temporarily open the blood–brain barrier in large, contoured regions. A median of four MB-FUS cycles were completed per patient (range 1-6), with some missed cycles due to COVID-19 disruptions.
Despite the small size of the study, patients treated with MB-FUS and temozolomide had significantly longer progression-free survival (13.5 months) and overall survival (31.3 months) compared with a carefully matched external control group treated with temozolomide alone, and the survival benefit remained consistent across multiple sensitivity analyses designed to account for bias. Side effects related to the focused ultrasound were mostly mild, with no unexpected safety concerns. These early results provide strong support for larger, randomized trials to test this treatment strategy.