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
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