Purpose : the aim of this study is to assess the feasibility and safety of ultrasound-induced opening of the blood-brain barrier (BBB) with the SonoCloud-9 implantable ultrasound device in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor treated with carboplatin. Study hypothesis : the blood-brain barrier can be transiently and safely opened with pulsed low intensity ultrasound immediately prior to intravenously delivered chemotherapy. The opening of the BBB with the SonoCloud-9 system will increase the tumor exposure to carboplatin and increase progression-free and overall survival in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor.
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Dose limiting toxicity directly linked to US emissions by the SonoCloud-9® (3 transducers)
Timeframe: Monthly up to 12 months
Dose limiting toxicity directly linked to US emissions by the SonoCloud-9®(3 transducers)
Timeframe: Monthly up to 12 months