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The median survival time remains at approximately 15 months following surgical resection and Temozolomide (TMZ) chemotherapy concurrent with radiotherapy 1. Global efforts to improve the prognosis for patients with glioblastoma (GBM) have been met with limited success. The characterization of therapeutic delivery and clinical response to this treatment paradigm requires further investigation. In this study, we demonstrated transient BBB opening in tumor and peritumor tissue using non-invasive low-intensity MRgFUS with systemically administered chemotherapy was safe and feasible. Biochemical analysis of sonicated versus unsonicated tissue suggest chemotherapy delivery is feasible. The BBB within the target volume showed radiographic evidence of opening with an immediate 15–50% increased contrast enhancement on T1-weighted MRI, and resolution approximately 20 hours after. The procedure was well-tolerated, with no adverse clinical or radiologic events related to the procedure. Samples of “sonicated” and “unsonicated” tissue were measured for the chemotherapy by liquid-chromatography-mass spectrometry. Five patients with previously confirmed or suspected high-grade glioma based on imaging underwent the MRgFUS in conjunction with administration of chemotherapy (n = 1 liposomal doxorubicin, n = 4 temozolomide) one day prior to their scheduled surgical resection. Our objective is to demonstrate safety and feasibility of MRgFUS BBB opening with systemically administered chemotherapy in patients with glioma in a phase I, single-arm, open-label study. In animals, MR-guided focused ultrasound (MRgFUS) with intravenously injected microbubbles can temporarily and repeatedly disrupt the BBB in a targeted fashion, without open surgery.
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The blood-brain barrier (BBB) has long limited therapeutic access to brain tumor and peritumoral tissue.