Status:
COMPLETED
Safety of BBB Opening With the SonoCloud
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Glioblastoma
Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 pa...
Detailed Description
For patients with recurrent malignant gliomas, who have already been treated by a combination of surgery, radiation therapy and/or chemotherapy, few treatment options currently exist. Salvage therapie...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02253212
Start Date
July 1 2014
End Date
July 1 2018
Last Update
October 12 2018
Active Locations (1)
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1
Groupe Hospitalier Pitié Salpetriere - Neurosurgery Department
Paris, France, 75013