Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption

NCT03551249 | Completed DMC FDA Device

• 1 other identifier: BT008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the safety of the ExAblate Model 4000 Type 2 used as a tool to disrupt the BBB (blood brain barrier) in patients with high grade glioma undergoing standard of care therapy.

Conditions

Glioblastoma; Glioma

Outcome Measures

Primary Outcomes (1)

• Device and procedure related adverse events

  The number and severity of device and BBB disruption procedure related adverse events will be evaluated and classified according to the CTCAE

  Throughout the study, approximately 12 months.

Secondary Outcomes (1)

• Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging

  At the time of each ExAblate MRgFUS procedure

Study Arms (1)

Focused Ultrasound (FUS)

EXPERIMENTAL

The ExAblate Model 4000 Type 2 system is intended for use as a tool to induce localized and temporary blood-brain barrier disruption in patients with glioblastoma undergoing initial standard of care chemotherapy.

Device: Focused ultrasound (FUS)

Interventions

Focused ultrasound (FUS) DEVICE

FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.

Also known as: ExAblate, Type 2

Focused Ultrasound (FUS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is eligible for adjuvant temozolomide (TMZ) treatment based on the current standard of care.
• Men or women age between 18 and 80 years, inclusive.
• Able and willing to give informed consent.
• Grade IV glioma (GBM)
• Combined radiation/TMZ treatment is completed based on the prescribed standard of care regimen.
• Karnofsky rating 70-100.
• Able to communicate during the ExAblate BBBD (Blood Brain Barrier Disruption) procedure.
• Able to attend all study visits (i.e., life expectancy of at least 3 months).

You may not qualify if:

• Patients presenting with the following imaging characteristics:
• i. Evidence of acute intracranial hemorrhage.
• The sonication pathway to the tumor involves:
• i. Extensive scalp sores. ii. Clips or other metallic implanted objects in the skull or the brain (brain implants)
• The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).
• Patients with cerebellar or brainstem tumors.
• Patients with positive HIV status.
• Significant depression not adequately controlled with medication and at potential risk of suicide.
• Patient receiving bevacizumab (Avastin) therapy.
• Patients receiving treatment with corticosteroid doses greater than dexamethasone 24 mg daily (or equivalent).
• Patients undergoing other concurrent therapies such as chemotherapy wafers, immunotoxins delivered by convection-enhanced delivery, regionally administered gene and viral therapies, immunotherapies, focal irradiation with brachytherapy, stereotactic radiosurgery, laser interstitial thermotherapy, and tumor treatment fields therapy.
• Cardiac disease or unstable hemodynamics including:
• i. Documented myocardial infarction within six months of enrollment. ii. Unstable angina on medication. iii. Congestive heart failure. iv. Left ventricular ejection fraction \<50%. v. History of a hemodynamically unstable cardiac arrhythmia. vi. Cardiac pacemaker.
• Severe hypertension (diastolic BP \> 100 on medication).
• Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment.

Sponsors & Collaborators

• InSightec: lead

Study Sites (4)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• Woodworth GF, Anastasiadis P, Ozair A, Chabros J, Bettegowda C, Chen C, Gerstl JVE, Douville C, Mekary RA, Smith TR, Meng Y, Hawkins C, Pople CB, Abrahao A, Llinas M, Heyn C, Bunevicius A, Rezai AR, Ball AJS, Henry K, Sahgal A, Torio E, Ren H, Ahmad H, Arora H, Eisenberg H, Perry J, Carpenter JS, Hynynen K, Pham LC, Anketell MB, Lim-Fat MJ, Xu Z, Cifarelli CP, Sheehan JP, McDannold NJ, Gandhi D, Golby AJ, Lipsman N. Microbubble-enhanced transcranial focused ultrasound with temozolomide for patients with high-grade glioma (BT008NA): a multicentre, open-label, phase 1/2 trial. Lancet Oncol. 2025 Dec;26(12):1651-1664. doi: 10.1016/S1470-2045(25)00492-9.

  PMID: 41308679 DERIVED

MeSH Terms

Conditions

Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Study Officials

• Graeme Woodworth, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: June 11, 2018
• Study Start: March 26, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)