Glioblastoma Clinical Trial: Focused Ultrasound Blood‑Brain Barrier Opening is Safe, Provides Possible Survival Benefit
Focused ultrasound–induced blood‑brain barrier opening prior to temozolomide chemotherapy is safe, feasible, and associated with a significant overall survival benefit in patients with newly diagnosed glioblastoma.
A multicenter, open‑label, phase 1/2 study (NCT03616860) enrolled 34 newly diagnosed glioblastoma patients who had undergone surgical resection and initial chemoradiotherapy. Participants received microbubble‑enhanced transcranial focused ultrasound (MB‑FUS) to open the blood–brain barrier immediately before each temozolomide cycle, with up to six cycles per patient. MB‑FUS was well tolerated, with no serious adverse events related to the procedure or device, and BBB opening was confirmed in all treatments. With a median follow‑up of 44.5 months, 41% of patients remained alive at end of the follow‑up, and the matched control group showed a 40% relative increase in overall survival. The study suggests that MB‑FUS improves temozolomide delivery and may extend survival in glioblastoma patients.
Improving chemotherapeutic delivery across the blood‑brain barrier could meaningfully extend survival for glioblastoma patients, who otherwise have a median survival of only 12–16 months.
Evidence level: Állatkísérletes. Állatmodellben vizsgálták.