Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by John de Groot, M.D.

Description

Summary

The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for liquid biopsy in subjects with suspected Glioblastoma brain tumors

Official Title

A Pivotal Study to Evaluate the Safety and Effectiveness of Exablate Model 4000 Using Microbubble Resonators to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors

Details

This is a prospective, multi-center, pivotal clinical trial to evaluate the safety and efficacy of targeted blood brain barrier disruption using Exablate Model 4000 Type 2 for liquid biopsy in subjects with suspected Glioblastoma brain tumors. The study will be conducted at up to 15 centers in the US.

Keywords

Glioblastoma, Glioma, Liquid Biopsy, Focused Ultrasound (Exablate Model 4000), Exablate BBBD

Eligibility

You can join if…

Open to people ages 18-80

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

You CAN'T join if...

  1. Tumor originating from the deep midline, thalamus, midbrain, cerebellum or brainstem.
  2. Multifocal tumors
  3. Tumor morphology or other imaging findings that precludes the ability to sonicate the planned tumor volume (including significant tumor volume outside the treatment envelope or tumor volume that exceeds the maximum sonication volume allowed, i.e. currently 110 ccs at the treatment volume level). Concern for adequate tumor coverage by sonication based on tumor morphology should be discussed with the Sponsor.
  4. MRI or clinical findings of:
    1. Active or chronic infection(s) or inflammatory processes
    2. Acute or chronic hemorrhages, specifically any lobar microbleeds, and no siderosis, amyloid angiopathy, or macro-hemorrhages
    3. Intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis
  5. MR non-compatible metallic implants in the skull or the brain or the presence of unknown MR unsafe devices
  6. Significant cardiac disease or unstable hemodynamic status
    1. Documented myocardial infarction within six months of enrollment
    2. Unstable angina on medication
    3. Unstable or worsening congestive heart failure
    4. Left ventricular ejection fraction below the lower limit of normal
    5. History of a hemodynamically unstable cardiac arrhythmia
    6. Cardiac pacemaker
    7. History of hypersensitivity to Perflutren lipid microsphere or its components, e.g., polyethylene glycol
  7. Uncontrolled hypertension (systolic > 180 and diastolic BP > 120 on medication)
  8. Unable to discontinue use of anti-coagulant/antiplatelet therapy as per local standard.
  9. History of a liver disease, bleeding disorder, coagulopathy or a history of spontaneous hemorrhage or evidence of increased risk of bleeding

    10. Abnormal coagulation profile (Platelets < 80,000), PT (>14) or PTT (>36), and INR >

    1.3

    11. Known cerebral or systemic vasculopathy 12. Significant depression and at potential risk of suicide 13. Known sensitivity/allergy to gadolinium or DEFINITY, 14. Active seizures despite medication treatment (defined as >1 seizure per week) which

    could be worsened by disruption of the blood brain barrier

    15. Active drug or alcohol disorder which have a higher risk for seizures, infection

    and/or poor executive functioning

    16. Positive HIV status, which can lead to increased entry of HIV into the brain

    parenchyma leading to HIV encephalitis

    17. Potential blood-borne infections which can lead to increased entry to brain parenchyma

    leading to meningitis or brain abscess

    18. Any contraindications to MRI scanning, including:

    1. Large subjects not fitting comfortably into the scanner
    2. Difficulty lying supine and still for up to 3 hours in the MRI unit or claustrophobia
      1. Impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2
      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
        1. Currently in a clinical trial involving an investigational product or non-approved use of a drug or device
        2. Pregnancy or Lactation

Locations

  • UCSF accepting new patients
    San Francisco California 94107 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCSF

  • John de Groot, M.D.
    Professor, Neurology, School of Medicine. Authored (or co-authored) 13 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
InSightec
ID
NCT05383872
Study Type
Interventional
Participants
Expecting 57 study participants
Last Updated