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

April 15, 2026 updated by: InSightec

Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to evaluate the safety and feasibility of BBB disruption using the Exablate Type 2.0 system in adult patients with glioblastoma (GBM) undergoing adjuvant TMZ chemotherapy, which occurs following maximal safe surgical resection and completion of the initial concurrent radiation-chemotherapy in accordance with the current standard of care

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20133
        • Fondazione IRCCS Neurologico Carlo Besta
  • Spain
    • Madrid
      • Móstoles, Madrid, Spain, 28938
        • CINAC-Hospital HM Puerta del Sur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.
Other Names:
  • Exablate Neuro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device and procedure related adverse events
Time Frame: Throughout the study, approximately 12 months.
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
Time Frame: At the time of each ExAblate MRgFUS procedure]
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]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InSightec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2021

Primary Completion (Actual)

July 27, 2023

Study Completion (Actual)

October 12, 2023

Study Registration Dates

First Submitted

July 27, 2020

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BT008E

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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