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

NCT04998864 | Completed DMC

• 1 other identifier: BT008E
• Study Type: observational
• Target: 3
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety of the Exablate Model 4000 Type 2.0 used as a tool to disrupt the BBB in patients with high grade glioma undergoing standard of care therapy.

Conditions

Glioma, Malignant; Glioblastoma

Keywords

Glioma, MRgFUS, Exablate, TMZ

Outcome Measures

Primary Outcomes (2)

• 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.

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

  The repeatability of BBB disruption will be evaluated at each of the 6 procedures and will be evaluated through assessment of post-procedure contrast-enhanced MR imaging.

  At the time of each ExAblate MRgFUS procedure]

Study Arms (1)

Focused Ultrasound (FUS) BBB Disruption

The Exablate Model 4000 Type 2.0 system is intended for use as a tool to induce localized and temporary blood-brain barrier disruption in patients with glioblastoma undergoing standard of care chemotherapy.

Device: Magnetic Resonance guided Focused ultrasound (MRgFUS)

Interventions

Magnetic Resonance guided Focused ultrasound (MRgFUS) DEVICE

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

Also known as: Exablate Neuro

Focused Ultrasound (FUS) BBB Disruption

Eligibility Criteria

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

Study Population

Patients with glioblastoma brain tumor who will undergo surgical resection and chemotherapy as standard of care with temozolomide.

You may qualify if:

• Patient is eligible for adjuvant TMZ treatment.
• Men or women age between 18 and 80 years, inclusive.
• Able and willing to give informed consent.
• Grade IV glioma (GBM) confirmed Subjects
• Karnofsky rating 70-100.
• Able to communicate during the Exablate BBBD procedure.
• Life expectancy of at least 3 months.

You may not qualify if:

• Evidence of acute intracranial hemorrhage.
• The subject presents with severe symptoms and signs of increased intracranial pressure
• Patients with cerebellar or brainstem tumors.
• Patients with positive HIV status
• Patients with brain tumors containing 1p/19q chromosomal co-deletion
• Patient receiving bevacizumab (Avastin) therapy
• Patients undergoing other concurrent therapies
• Cardiac disease or unstable hemodynamics
• Severe hypertension
• Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment
• History of a bleeding disorder and/or coagulopathy
• Known sensitivity to gadolinium-based contrast agents
• Known sensitivity to ultrasound contrast agent
• Severely impaired renal function
• Subjects with significant liver dysfunction

Sponsors & Collaborators

• InSightec: lead

Study Sites (2)

Fondazione IRCCS Neurologico Carlo Besta

Milan, 20133, Italy

Location

CINAC-Hospital HM Puerta del Sur

Móstoles, Madrid, 28938, Spain

Location

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 Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 10, 2021
• Study Start: August 25, 2021
• Primary Completion: July 27, 2023
• Study Completion: October 12, 2023
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

ES (1); IT (1)