​This is a phase III, randomized, open-label, multicentric, two-arm trial of SonoCloud-9 combined with carboplatin vs standard of care lomustine or temozolomide in patients undergoing planned resection for first recurrence of glioblastoma. The SonoCloud-9 uses ultrasound technology and is specially developed to transiently open the blood-brain barrier (BBB) in the area of and surrounding the tumor where most of therapeutic agents cannot readily penetrate. The BBB is located at the level of blood vessels walls and protects the brain from any toxic or inflammatory molecules, but it also prevents most drugs injected in the bloodstream from getting into brain tissue where the tumor is seated.

The study is designed to evaluate and compare the survival outcome of patients with first recurrence of glioblastoma undergoing surgical debulking/resection followed by either implantation of the SonoCloud-9 device and repeat BBB opening in association with carboplatin chemotherapy or standard of care second line chemotherapy with either lomustine or temozolomide (per best physician's choice and best practice).

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Local principal investigator: Jane Skjøth-Rasmussen

Local sub-investigator: Alexander Lilja-Cyron

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