Overview

Safety of BBB Opening With the SonoCloud

Status:
Completed
Trial end date:
2018-07-01
Target enrollment:
Participant gender:
Summary
PURPOSE: The purpose of this study is to determine whether transient opening of the blood-brain barrier by pulsed ultrasound using the SonoCloud implantable ultrasound device is safely tolerated in patients with recurrent glioblastoma immediately before systemic delivery of carboplatin-based chemotherapy. STUDY HYPOTHESIS: The blood-brain barrier can be safely opened using pulsed ultrasound prior to chemotherapy administration in patients with recurrent glioblastoma. Transient opening of the blood-brain barrier by pulsed ultrasound will increase the glioblastoma exposure to carboplatin-based chemotherapy and increase progression-free and overall survival in patients with recurrent glioblastoma.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
Carboplatin