Innovative SonoCloud-9 Device for Blood Brain Barrier Opening in First Line Temozolomide Glioblastoma Patients.
Status:
Recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
Summary
Glioblastoma (GBM) is an aggressive cancer with a progression-free survival (PFS) of 7 months
and an overall survival (OS) of 15 months. Many therapeutic approaches have failed to improve
the prognosis of patients to date. One of the main reasons is the presence of blood brain
barrier (BBB) which limits therapeutic agents uptake in the brain. GBM is also considered to
have a "cold" (unresponsive) immunological microenvironment due to factors released by the
tumor and the presence of BBB limiting the transit of immune cells from the systemic
circulation. Therefore, by-passing the BBB appears as a promising strategy.
The objective of the Phase II clinical trial, SonoFIRST, is to evaluate if the use of
therapeutic ultrasound device, sonoCloud-9 (SC9) could improve the progression free survival
of newly diagnosed GBM patients, treated by concurrent temoradiation and adjuvant
temozolomide. The transient opening of the BBB by ultrasound with the SonoCloud-9 (SC9)
device, predicts the increase in the penetration of temozolomide (TMZ) into the brain and the
stimulation of cerebral immunity with the prospect of improving the survival of 160,000 new
brain tumor patients each year in Europe and the United States.