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.
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)
weight <15kg
significant intra-tumoral bleeding (hematoma) or ipsilateral subdural effusion
6 weeks for nitrosoureas
1 month for temozolomide
Single group
SonoCloud® (9 transducers)
DeviceSonoCloud®, sonication: dose escalation 6 cycles of sonication
Dose limiting toxicity directly linked to US emissions by the SonoCloud-9® (3 transducers)
Clinical evaluation (neurological deficit, intracranial hypertension, epilepsy) during acoustic pressure dose escalation, after each sonication (48h)
Dose limiting toxicity directly linked to US emissions by the SonoCloud-9®(3 transducers)
Radiological evaluation (hemorrage, ischemia, brain swelling) during acoustic pressure dose escalation, after each sonication
BBB opening intensity with the SonoCloud® device
Grading of BBB disruption using the scale previously described (Carpentier et al 2016), after each sonication
Clinical efficacy of BBB disruption by the SonoCloud® device in association with systemic chemotherapy
Overall Survival (OS)
Clinical efficacy of BBB disruption by the SonoCloud® device in association with systemic chemotherapy
Overall Survival (OS)
Radiological efficacy of BBB disruption by the SonoCloud® device in association with systemic chemotherapy
Progression Free Survival (PFS) using RANO Criteria
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
CarThera
Collaborator
Gustave Roussy, Cancer Campus, Grand Paris
Collaborator
Institut Curie
Collaborator
URC-CIC Paris Descartes Necker Cochin
Collaborator
