Safety Study of the Repeated Opening of the Blood-brain Barrier With the SonoCloud® Device to Treat Malignant Brain Tumors in Pediatric Patients

Inclusion Criteria: * patient aged ≥ 5 years old and \< 18 years old * patient able to receive sonications and perform MRI studies without sedation * diagnosis of supra-tentorial primary malignant brain tumor (e.g. malignant glioma, embryonal tumor including ATRT, ependymoma) * recurrence or progression of brain tumor after at least a first line of standard treatment (multifocal tumors and metastatic disease allowed) * indication of treatment with carboplatin, validated in multidisciplinary meeting * Karnofsky performance scale index (patients ≥ 16 years old) or Lansky performance status (patients \< 16 years old) \> 50% (a patient with a performance status score altered by a motor deficit due to tumor infiltration will be allowed to be included) * no threat of brain herniation or uncontrolled intracranial hypertension * corticosteroids treatment ≤ 1mg/kg/day * neutrophils \> 1.5 x 109/L * platelets \> 100 x 109/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) * no grade 2 or more toxicity depending on the NCI-CTCAE v5.0 criteria * no healed wound on the scalp * covered by health insurance * for patients of chilbearing age (15-17 years old) : a negative pregnancy test and an efficient method of birth control * written consent signed by the patient (if possible) and his parents or legal representatives. Exclusion Criteria: * weight \<15kg * significant intra-tumoral bleeding (hematoma) or ipsilateral subdural effusion * 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 for the first sonication session * radiotherapy during the last 6 weeks * any other cancer treated during the last 5 years * any other uncontrolled disease or active infection * any other co-morbidity that could compromise participation to the study (in the judgement of the clinical investigator) * any anatomical particularity (skull thickness, thin skin) that could compromise a safe implantation of the device and/or compromise the quality of the treatment (in the judgement of the clinical investigator) * implanted defibrillator/pacemaker, neurostimulator, cochlear implant, intracerebral ferromagnetic vascular clip * any contraindication to general anesthesia * any contraindication to MRI or known allergy to gadolinium or other MRI contrast agent/ * any contraindication to ultrasound contrast agent: * allergy to the active substance or any excipient * acute coronary syndrome or uncontrolled ischemic heart disease * chronic heart failure or history of acute heart failure or heart failure grade III or IV * treatment with dobutamine * severe pulmonary arterial hypertension * uncontrolled systemic hypertension * respiratory distress syndrome * carboplartin hypersensitivity * treatment with phenytoin or fosphenytoin * earlier vaccination with attenuated alive vaccine * diminished auditory acuity ≥ grade 3 on CTCAE classification * history of thermoregulation disorder * impossibility of a rigorous medical follow-up due to geographic, social or mental reasons * pregnant and lactating women * contemporaneous treatment by anticoagulant or platelet aggregation inhibiting drugs * contemporaneous treatment possibly toxic for the central nervous system. The following treatments are excluded if taken less than 5 half-lives before the ultrasound session (unknown toxicity in case of BBB disruption) : * benzodiazepine (or any sedative or hypnotique drug) * antihistamine * proconvulsant drugs * butyrophenone, phenothiazine, or any "conventional" antipsychotic drug * barbiturate * MAO inhibitor * anticholinergic * anticoagulant * any contemporaneous treatment that, in the judgement of the clinical investigator, could induce brain toxicity after BBB disruption