Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors

Completed · Not applicable

Conditions studied: Glioblastoma, Glioma, Liquid Biopsy

In brief

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

Key facts

Study ID

NCT05383872

Run by

InSightec

People needed

71

Starts

2022-08-08

Expected to finish

2025-03-05

Last updated by the study team

2025-07-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female subjects18-80 years of age who are able and willing to give informed consent, or whose legally authorized representative is willing to consent on their behalf
• Subjects with stereotactically-targetable suspected new or recurrent 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

You may not qualify if…

• Subjects with inoperable tumors (e.g., tumor originating from the deep midline, thalamus, midbrain, cerebellum or brainstem)
• Multifocal tumors
• Tumor morphology or other imaging findings that precludes the ability to sonicate the 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.
• 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
• Documented left ventricular ejection fraction below the lower limit of normal
• History of a hemodynamically unstable cardiac arrhythmia
• Cardiac pacemaker
• Uncontrolled hypertension (systolic > 180 and diastolic BP > 120 on medication)
• Undergoing anti-coagulant or anti-platelet therapy, or using medications known to increase risk of hemorrhage within washout period 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 bleeding disorder, coagulopathy or a history of spontaneous hemorrhage or evidence of increased risk of bleeding
• Abnormal coagulation profile (Platelets < 80,000, PT >14, PTT >36, or INR > 1.3)
• Known cerebral or systemic vasculopathy
• Significant depression and at potential risk of suicide
• Known sensitivity/allergy to gadolinium or DEFINITY/DEFINITY RT,
• 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
• Known positive HIV status, which can lead to increased entry of HIV into the brain parenchyma leading to HIV encephalitis

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• University of California San Francisco — San Francisco, California, United States
• UF Health Shands Hospital — Gainesville, Florida, United States
• Miami Cancer Institute at Baptist Health — Miami, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• University of Maryland, Baltimore & The University of Maryland Medical System — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• NYU Grossman School of Medicine — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• University of Texas, Southwestern — Dallas, Texas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• West Virginia University Rockefeller Neuroscience Center — Morgantown, West Virginia, United States
• Sunnybrook Research Institute — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.