Testing Focused Ultrasound Next Generation Dome with Definity® Vial for (Perflutren Lipid for GBM

Exclusion

• −Allergy to eggs or egg products.
• −Subjects with a history of drug allergies, asthma or hay fever, and multiple allergies, in particular subjects with a history of anaphylaxis.
• −Subjects with evidence of Hepatitis B virus infection/carrier state.
• −Patients presenting with the following imaging characteristics:
• −i. Following steroid treatment, brain edema and/or mass effect that causes midline shift or shift in wall of the third ventricle of more than 10 mm.
• −ii. Evidence of recent (less than 2 weeks) intracranial hemorrhage. iii. Calcifications in the FUS sonication beam path in the event system tools cannot tailor the treatment around these calcification spots.
• −The sonication pathway to the tumor involves:
• −i. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
• −ii. Clips or other metallic implanted objects in the skull or the brain, except shunts.
• −The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).
• −Patients requiring increasing doses of corticosteroids.
• −Patient receiving bevacizumab (Avastin) therapy.
• −Cardiac disease or unstable hemodynamics including:
• −i. Documented myocardial infarction within six months of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →. ii. Unstable angina on medication. iii. Congestive heart failure. iv. Left ventricular ejection fraction \<50%. v. History of a hemodynamically unstable cardiac arrhythmia. vi. Cardiac pacemaker.
• −Severe hypertension (diastolic blood pressure (DBP) \> 100 on medication).
• −Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout periodWashout periodA gap with no treatment, so the previous one clears your system.Read more → prior to treatment (i.e., antiplatelet or vitamin K inhibitor anticoagulants within 7 days, non-vitamin K inhibitor anticoagulants within 72 hours, or heparin-derived compounds within 48 hours of treatment).
• −History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage.
• −Abnormal level of platelets (\< 100,000) or INR \> 1.3.
• −Documented cerebral infarction within the past 12 months.
• −TIA in the last 1 month.
• −Cerebral or systemic vasculopathy.
• −Insulin-dependent diabetes mellitus that is not well-controlled or that in the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion precludes participation in the study.
• −Known sensitivity to gadolinium-DTPA.
• −Known sensitivity to DEFINITY® ultrasound contrast agent or perflutren.
• −Contraindications to MRI such as non-MRI-compatible implanted devices, unable to tolerate an MRI due to for instance pain or claustrophobia, untreated, uncontrolled sleep apnea.
• −Known life-threatening systemic disease.
• −Severely impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2 and/or on dialysis.
• −Right to left or bi-directional cardiac shunt.
• −Previous radiotherapy.
• −Subjects with evidence of cranial or systemic infection.
• −Subjects with chronic pulmonary disorders.
• −Subjects with a family or personal history of QT prolongation or taking concomitant medications known to cause QTc prolongation, or QT prolongation observed on screeningScreeningThe checks done before joining, to see whether a study fits.Read more → ECG (QTc \> 450 for men and \>470 for women).
• −Liver injury as indicated by liver function tests that in the Investigator's opinion precludes participation in the study.
• −Positive pregnancy test (for pre-menopausal women).
• −Patients with ≥25% increase in volume of contrast enhancement at time of assessment for study enrollment, compared with their first postoperative MRI. This cut-off is used to differentiate between pseudoprogression (which can occur following both radiation and TMZ therapy) and true tumor progression. This will be further ascertained through a discussion between the study neurosurgeons and radiologists.
• −Patients undergoing other concurrent therapies such as chemotherapy wafers, immunotoxins delivered by convection-enhanced delivery, regionally administered gene and viral therapies, immunotherapies, and focal irradiation with brachytherapy, stereotactic radiosurgery, and laser interstitial thermotherapy. These regimens have been shown to cause contrast enhancement in the resection cavity boundary, which can be difficult to differentiate from true tumor recurrence.
• −Previous full course of chemotherapy for GBM (at the discretion of investigator).