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 (Jun 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
Treatments studied
Other
Cancer type
Glioblastoma
Demographics
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.
Frequently asked questions
Is NCT05293197 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antineoplastic treatment other than carboplatin, radiotherapy, any other cancer treatment disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 17 years or younger and at least 5 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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