Carthera, developer of the SonoCloud medical device, today announced it has enrolled the first 100 patients in its SONOBIRD pivotal trial for the treatment of recurrent glioblastoma using ultrasound for the temporary opening of the blood-brain-barrier (BBB).
Nearly all 40 participating sites across Europe and the U.S. are now active. Carthera anticipates that recruitment will continue to reach the 560 patients planned for the study.
The company said the trial is the world’s first randomized, multi-centric, two-arm pivotal trial of BBB opening prior to chemotherapy injection in recurrent glioblastoma patients. Tthe trial makes use of the SonoCloud, an ultrasound-based medical device developed by Carthera to treat a wide range of brain disorders. Specifically, the trial compares the use of SonoCloud combined with carboplatin versus standard therapies in patients with a first recurrence of glioblastoma.
To date, more than 550 SonoCloud treatments have been performed worldwide.
Initiated in February 2024, the registrational study aims to enroll a total of 560 US and EU patients within two years, with a view to obtaining marketing authorization. The first interim analysis of the clinical data will be available soon.
