Glioma, MalignantNCT04998864
Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption in GBM Patients
An observational study of Glioma, Malignant and Glioblastoma, run by InSightec at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioma, Malignant, Glioblastoma
- What is being tested?
- Magnetic Resonance guided Focused ultrasound (MRgFUS)
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Aug 2021to 12 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with glioblastoma brain tumor who will undergo surgical resection and chemotherapy as standard of care with temozolomide.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read the 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
- Conditions
- Glioma, Malignant, Glioblastoma
- Being tested
- Magnetic Resonance guided Focused ultrasound (MRgFUS)
- Keywords
- Glioma, MRgFUS, Exablate, TMZ
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance guided Focused ultrasound (MRgFUS)Device
Also called Exablate Neuro
FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Magnetic Resonance guided Focused ultrasound (MRgFUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At the time of each ExAblate MRgFUS procedure]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start25 Aug 2021
- Primary completion27 Jul 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma, MalignantStudies of the same condition, open and under way.
- More trials run by InSightecThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998864
- Sponsor's protocol ID
- BT008E
- Status last verified
- Apr 2026
- First submitted
- 27 Jul 2020
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy
- ClinicalTrials.gov ID
- NCT04998864
- Acronym / sponsor ID
- BT008E
- Conditions
- Glioma, Malignant, Glioblastoma
- Keywords
- Glioma, MRgFUS, Exablate, TMZ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focused Ultrasound (FUS) BBB Disruption | – | Device: Magnetic Resonance guided Focused ultrasound (MRgFUS)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with glioblastoma brain tumor who will undergo surgical resection and chemotherapy as standard of care with temozolomide.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance guided Focused ultrasound (MRgFUS)Also: Exablate NeuroFUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets. | Device | Focused Ultrasound (FUS) BBB Disruption |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, Malignant and Glioblastoma, run by InSightec at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device and procedure related adverse events (time frame: Throughout the study, approximately 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.