Safety and Efficacy of Transient Opening of the Blood-brain Barrier (BBB) With the SonoCloud-9

Key Inclusion Criteria:

1. Age ≥ 18 years, able and willing to give signed and informed consent.

2. Patient with histologically proven recurrent de novo GBM:

   1. After at least a first-line standard of care (maximal safe resection, if feasible, radiation with temozolomide [TMZ], then TMZ);
   2. Any recurrence;
   3. Bevacizumab-naïve.*
3. Patient eligible for carboplatin-based chemotherapy.
4. Patient eligible for a surgical resection.
5. Maximal tumor diameter at inclusion (pre surgery) ≤ 70 mm in T1wMRI.
6. Patients should be stable, without evidence of a midline shift, significant peritumoral edema, or rapid progression of clinical symptoms.
7. Karnofsky performance status ≥ 70.
8. Patient receiving prednisone dose ≤ 40 mg (dexamethasone ≤ 6 mg) for at least 7 days.

Key Exclusion Criteria:

1. Multifocal tumor (unless all localized in a 70 mm diameter area).
2. Patients at risk of surgery site infection (2 or more previous craniotomies, neurosurgery within the last 3 months, poor skin condition, and/or previously infected surgical field).
3. Posterior fossa tumor.
4. Uncontrolled epilepsy.
5. Patients with evidence of uncontrolled intracranial pressure.
6. Patients with known intracranial aneurism or having presented intra-tumor spontaneous hemorrhage.
7. Patients with coils, clips, shunts, intravascular stents, and/or unremovable wafer, non resorbable dura substitute, or reservoirs.
8. Patients with medical need to continue antiplatelet therapy.
9. Patients with known or suspected active or chronic infections.