A randomized, open-label, multicentric, two-arm pivotal trial of SonoCoud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma

The purpose of this study is to see if the implantable device, Sonocloud 9, is effective getting chemotherapy to better reach your tumor compared to receiving standard of care chemotherapy [Temozolomide and Lomustine] and to see how safe and tolerable the device is. Sonocloud 9 works by making the blood-brain barrier (BBB) more permeable(allowing liquids or gases to go through it) so chemotherapy can better reach your tumor. The BBB is a natural sealing of the blood vessels in the brain. This study is being done in participants whose brain tumor has returned and are eligible for surgery to have it removed. SC9 is an investigational device specially developed to allow an opening of the BBB in the area of and surrounding area of the tumor at the time of a chemotherapy cycle. Investigational means that the device is not approved by the U.S. Food and Drug Administration (FDA). Chemotherapy associated with BBB opening by Sonocloud-9 is Carboplatin. Carboplatin is a drug that has been used for treatment of ovarian cancer for over 30 years and it is used in combination with other drugs, to treat different cancer types.

Are you Eligible? (Inclusion Criteria)

• Must be 18 years old or older. - Must be a candidate for craniotomy and at least 50% removal of tumor region. - Must not be pregnant or breastfeeding for the duration of the study and for 1 month after treatment is over.