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

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-fre

Trial Details

NCT ID
NCT05293197
Phase
PHASE1
Sponsor
Assistance Publique - Hôpitaux de Paris
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • SonoCloud® (9 transducers)
Locations (sample)
  • Paris, France|48.85341,2.3488
  • Paris, France|48.85341,2.3488
  • Villejuif, France|48.7939,2.35992

Key Eligibility 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)

For full eligibility, visit ClinicalTrials.gov.

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