Sonofirst presentation

European Phase II randomised, open-label, multi-centre project Identifier: NCT04614493:

Number of patients: 66 participants

Treatment :

  • Experimental arm: Patients receiving standard reference treatment (Stupp Protocol: surgery, focal radiotherapy, chemotherapy with temozolomide) with ultrasound from the SC9 device. Patients will be implanted with the SC9 device.
  • Reference arm: Patients receiving the reference treatment (Protocol Stupp: surgery, focal radiotherapy, chemotherapy with temozolomide) without ultrasound. There will be no implantation of the SC9 device.

Study duration: 30 months

Inclusion period: 12 months

Study start date: June 2021

Expected study completion date: December 2023

Duration of participation: 18 months (last patient), up to 30 months for 1st patient included

Primary objective: Clinical efficacy based on comparison of median PFS (progression-free survival) assessed by the local investigator between standard of care treatment with ultrasound BBB opening and standard of care treatment alone.

Number of recruiting sites: 7 of which 5 in France, 1 in Belgium and 1 in Switzerland