Ensayos clínicos

Inclusion Criteria:

• Male or female.
• Between > 18-80 years of age.
• Able and willing to give informed consent 
• Subjects with a suspected glioblastoma tumor on pre-operative brain imaging scans.
• Subjects that are scheduled, or will be scheduled within 4 weeks, for surgical resection or biopsy per standard clinical tumor care.
• Karnofsky Performance Score > 70.
• Able to communicate sensations during the Exablate BBBD procedure.

Exclusion Criteria:

• Tumor originating from the deep midline, thalamus, midbrain, cerebellum or brainstem.
• Multifocal tumors.
• MRI or clinical findings of:
  • Active or chronic infection(s) or inflammatory processes;
  • Acute or chronic hemorrhages, specifically any lobar microbleeds, and no siderosis, amyloid angiopathy, or macro-hemorrhages;
  • Intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis.
• MR non-compatible metallic implants in the skull or the brain or the presence of unknown MR unsafe devices.
• Significant cardiac disease or unstable hemodynamic status:
  • Documented myocardial infarction within six months of enrollment;
  • Unstable angina on medication;
  • Unstable or worsening congestive heart failure;
  • Left ventricular ejection fraction below the lower limit of normal;
  • History of a hemodynamically unstable cardiac arrhythmia;
  • Cardiac pacemaker;
  • History of hypersensitivity to Perflutren lipid microsphere or its components; e.g., polyethylene glycol.
• Uncontrolled hypertension (systolic > 180 and diastolic BP > 120 on medication).
• Unable to discontinue use of anti-coagulant/antiplatelet therapy as per local standard.
• History of a liver disease, bleeding disorder, coagulopathy or a history of spontaneous hemorrhage or evidence of increased risk of bleeding.
• Abnormal coagulation profile (Platelets < 80,000), PT (> 14) or PTT (> 36), and INR > 1.3.
• Known cerebral or systemic vasculopathy.
• Significant depression and at potential risk of suicide.
• Known sensitivity/allergy to gadolinium or DEFINITY®.
•  Active seizures despite medication treatment (defined as > 1 seizure per week) which could be worsened by disruption of the blood brain barrier.
• Active drug or alcohol disorder which have a higher risk for seizures, infection and/or poor executive functioning.
• Positive HIV status, which can lead to increased entry of HIV into the brain parenchyma leading to HIV encephalitis.
• Potential blood-borne infections which can lead to increased entry to brain parenchyma leading to meningitis or brain abscess.
• Any contraindications to MRI scanning, including:
  • Large subjects not fitting comfortably into the scanner;
  • Difficulty lying supine and still for up to 3 hours in the MRI unit or claustrophobia.
• Impaired renal function with estimated glomerular filtration rate < 30 mL/min/1.73m^2.
• Severe Respiratory Illness: chronic pulmonary disorders; e.g.,severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area, subjects with a history of severe drug allergies, asthma or hay fever, and multiple allergies where the benefit/risk of administering Definity® is considered unfavorable by the study physicians in relation to the product labeling for Definity®.
• Currently in a clinical trial involving an investigational product or non-approved use of a drug or device.
• Pregnancy or lactation.