Safety of BBB Opening With the SonoCloud

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

PURPOSE: The purpose of this study is to determine whether transient opening of the blood-brain barrier by pulsed ultrasound using the SonoCloud implantable ultrasound device is safely tolerated in patients with recurrent glioblastoma immediately before systemic delivery of carboplatin-based chemotherapy.

STUDY HYPOTHESIS: The blood-brain barrier can be safely opened using pulsed ultrasound prior to chemotherapy administration in patients with recurrent glioblastoma. Transient opening of the blood-brain barrier by pulsed ultrasound will increase the glioblastoma exposure to carboplatin-based chemotherapy and increase progression-free and overall survival in patients with recurrent glioblastoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Carboplatin

Criteria

Inclusion criteria:

• Age greater than 18 years.

• Subjects with recurrent glioma who have failed standard therapy with surgery and/or treatment with radiation and temozolomide.

• Patient eligible for Carboplatin-based chemotherapy

• Contrast-enhanced tumor less than 35 mm in diameter

• No risk of cerebral herniation

• Able to tolerate pre/post procedure steroid treatment

• Social security affiliated (in France)

• Able and willing to give signed and informed consent

• Normal biological status

• Hemoglobin ≥ 10 g/dl

• Platelets ≥ 100000/mm3

• Neutrophils ≥ 1500/mm3

• Normal creatine clearance ≥ 60ml/mn

• ASAT < 3 N

• ALAT < 3 N

• Normal Bilirubin Level < 1.5 N

• Alkaline Phosphatase < 3 N

• INR < 1.5

• Prothrombin Level ≥ 70%

Exclusion criteria:

• Allergic to Iodine, Gadolinium, Xylocain

• Contra-indications to echographic contrast agent (microbubbles)

• Severe Renal insufficiency

• Hepatic insufficiency

• Possible toxic treatment for CNS

• Previously infected surgical field

• Uncontrolled epilepsy

• MRI contra-indications

• Hemostasis troubles thrombopenia <75.000, TP <60%, INR >1.5, anti-platelet or anticoagulant therapy on-going)

• Active phlebitis or active pulmonary embolism

• Pregnant or currently breast-feeding

• Patients under judicial protection