European Phase II randomised, open-label, multi-centre project
ClinicalTrials.gov Identifier: NCT04614493: https://clinicaltrials.gov/ct2/show/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