OncoMatch/Clinical Trials/NCT05293197
Safety Study of the Repeated Opening of the Blood-brain Barrier With the SonoCloud® Device to Treat Malignant Brain Tumors in Pediatric Patients
Is NCT05293197 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies SonoCloud® (9 transducers) for malignant brain tumor.
Treatment: SonoCloud® (9 transducers) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Prior therapy
Must have received: standard treatment
recurrence or progression of brain tumor after at least a first line of standard treatment
Cannot have received: antineoplastic treatment other than carboplatin
Exception: allowed if stopped for specified washout periods
antineoplastic treatment other than carboplatin taken at the same time or stopped since less than: 6 weeks for nitrosoureas, 1 month for temozolomide, 1 month for bevacizumab, 5 half-lives for tyrosin kinase inhibitors, 3 weeks for any other chemotherapy
Cannot have received: radiotherapy
Exception: allowed if stopped for >= 6 weeks
radiotherapy during the last 6 weeks
Cannot have received: any other cancer treatment
any other cancer treated during the last 5 years
Lab requirements
Blood counts
neutrophils > 1.5 x 10^9/L; platelets > 100 x 10^9/L; coagulation parameters in the normal limits for age (fibrinogen, prothrombin time and activated clotting time)
Kidney function
serum creatinin < 1.5x upper limit of normal for the age or creatinine clearance >70mL/min/1.73m2 (EDTA method or 24h urine)
Liver function
total bilirubin < 1.5x upper limit of normal, AST and ALT < 2.5x upper limit of normal
neutrophils > 1.5 x 10^9/L; platelets > 100 x 10^9/L; total bilirubin < 1.5x upper limit of normal, AST et ALT < 2.5x upper limit of normal; serum creatinin < 1.5x upper limit of normal for the age or creatinine clairance >70mL/min/1.73m2 (EDTA method or 24h urine); coagulation parameters in the normal limits for age (fibrinogen, prothrombin time and activated clotting time)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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