Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02253212 : Safety of BBB Opening With the SonoCloud
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02253212      |      Link to official Clinicaltrials.gov listing
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