Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-003261
NCT ID: NCT05383872
Sponsor Protocol Number: BT015
About this study
The purpose of this study is to evaluate the safety and effectiveness of using Exablate Model 4000 Type-2.0/2.1 in adults with Glioblastoma brain tumors to increase temporarily the permeability of the blood brain barrier, allowing increased passage of circulating free DNA (cfDNA) for sampling and analysis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available