ExAblate Blood Brain Barrier Disruption (BBBD) for Planned Surgery in Suspected Infiltrating Glioma
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ClinicalTrials.gov Identifier: NCT03322813 |
Recruitment Status :
Suspended
(Study temporarily suspended until priorities are reassessed)
First Posted : October 26, 2017
Last Update Posted : August 3, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioma | Device: ExAblate 4000 - Type 2 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Study to Evaluate the Safety and Feasibility of Exablate Model 4000 Type-2 to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) in Patients With Suspected Infiltrating Glioma in the Setting of Planned Surgical Interventions |
Estimated Study Start Date : | October 2023 |
Estimated Primary Completion Date : | September 2024 |
Estimated Study Completion Date : | December 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: ExAblate 4000 - Type 2
ExAblate BBBD
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Device: ExAblate 4000 - Type 2
Using ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma undergoing resection
Other Name: ExAblate BBBD |
- Device and procedure related adverse events [ Time Frame: At the time of the ExAblate MRgFUS procedure ]The number and severity of device and BBBD procedure related adverse events will be evaluated.
- Feasibility of BBB disruption [ Time Frame: At the time of the ExAblate MRgFUS procedure and 24 hours post-procedure ]The extent and reversibility of BBB opening will be determined by the degree of contrast enhancement seen on post-procedure MRI with contrast agent

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Ages Eligible for Study: | 21 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or Female between 21-85 years of age
- Able and willing to give informed consent
- Subjects with suspected infiltrating glioma on pre-operative brain imaging scans including non-enhancing MRI tumor components in non-eloquent regions that are within the planned surgical resection volume
- Surgical area targeted for ExAblate treatment (i.e. prescribed Region of Treatment) ≤30 cm3; planned surgical resection volume may exceed the targeted treatment volume
- Karnofsky Performance Score 70-100
- Able to communicate sensations during the ExAblate® BBBD procedure
Exclusion Criteria:
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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 macrohemorrhages
- Intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis
- Evidence of tumor-related calcification, cyst, or hemorrhage
- Midline shift of >10mm or evidence of subfalcine, uncal, or tonsillar herniation on pre-operative imaging
- 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
- Clips, shunts, or any metallic implanted objects in the skull or the brain or the presence of unknown MR unsafe devices anywhere within the body
- Significant cardiac disease or unstable hemodynamic status
- Uncontrolled hypertension (systolic > 150 and diastolic BP > 100 on medication)
- Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk of hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
- History of a liver disease, bleeding disorder, coagulopathy or a history of spontaneous hemorrhage
- Abnormal coagulation profile (Platelets < 100,000), PT (>14) or PTT (>36), and INR > 1.3
- Lacunar lesions or evidence of increased risk of bleeding
- Known cerebral or systemic vasculopathy
- Significant depression and at potential risk of suicide
- Known sensitivity/allergy to gadolinium, or other intravascular contrast agents
- Active seizures despite medication treatment (defined as >1 seizure per month) which could be worsened by disruption of the blood brain barrier
- Evidence of worsening neurological function
- Dexamethasone dose ≥ 24mg daily or equivalent steroid dose
- History of 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
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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
- Untreated, uncontrolled sleep apnea
- Impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2
- Respiratory: chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area, patients with a history of 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322813
United States, Maryland | |
University of Maryland Medical System | |
Baltimore, Maryland, United States, 21201 |
Principal Investigator: | Graeme Woodworth, MD | University of Maryland |
Responsible Party: | InSightec |
ClinicalTrials.gov Identifier: | NCT03322813 |
Other Study ID Numbers: |
BT004 |
First Posted: | October 26, 2017 Key Record Dates |
Last Update Posted: | August 3, 2022 |
Last Verified: | August 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Glioblastoma Blood Brain Barrier BBB |
ExAblate Blood Brain Barrier Disruption Infiltrating glioma |
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |