A phase 1/2a clinical trial is currently in progress to study the transient opening of the blood-brain barrier (BBB) using the SonoCloud® during chemotherapy administration in patients with recurrent glioblastoma.
This study is a prospective multidisciplinary single-arm mono-center study that is being performed by the departments of Neurosurgery and Neuro-Oncology at the Hospital Pitie Salpetriere. The study sponsor is l’Assistance Publique des Hôpitaux de Paris.
The study addresses patients with gliobastoma that have experienced recurrence after initial standard of care treatments and who are eligible for carboplatin chemotherapy. Patient inclusion is discussed on a case by case basis during multidisciplinary department meetings.
The goal of this Phase 1/2a clinical study is to temporarily disrupt the BBB using low intensity pulsed ultrasound during chemotherapy sessions with carboplatin, with the goal of increasing the concentration of chemotherapeutic agent in the brain tissue. Additional information is available on the site clinicaltrials.gov: