GliomaBBBDNCT04667715
Safety and Effectiveness of Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma
A study testing Exablate BBBD in people with Glioma, run by InSightec at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of using the Exablate Type 2 system using microbubble resonators (Exablate Test Arm) to disrupt the Blood-Brain Barrier for the purpose of temporarily transforming, and thereby 'marking', regions of infiltrating gliomas prior to planned surgical… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Glioma
- What is being tested?
- Exablate BBBD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Oct 2024to 23 Oct 2024
- Phase
- Interventional
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female between 21-85 years of age who are able and willing to give informed consent
- Subjects with suspected Grade II, III or IV infiltrating glioma (IG) on pre-operative brain imaging scans who have a non-enhancing component and are planned for surgical resection.
- Karnofsky Performance Score 70-100
- Able to communicate sensations during the Exablate BBBD procedure
Who cannot join
- Tumor originating from the deep midline, thalamus, midbrain, cerebellum or brainstem.
- Multifocal tumors
- 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 macro-hemorrhages
- Intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis
Show all 36Show fewer
- 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
- MR non-compatible metallic implants in the skull or the brain or the presence of unknown MR unsafe devices
- Significant cardiac disease or unstable hemodynamic status
- Documented myocardial infarction within six months of enrollment
- Unstable angina on medication
- Unstable or worsening congestive heart failure
- Left ventricular ejection fraction below the lower limit of normal
- History of a hemodynamically unstable cardiac arrhythmia
- Cardiac pacemaker
- Patient has right-to-left, bidirectional, or transient right-to-left cardiac shunts
- Subjects with relative contraindications to perflutren including subjects with a family or personal history of QT prolongation or taking concomitant medications known to cause QTc prolongation,
- Perflutren sensitivity or allergy ii. QT prolongation observed on screening ECG (QTc > 450 for men and >470 for women)
- Uncontrolled hypertension (systolic > 180 and diastolic BP > 120 on medication)
- Unable to discontinue use of anti-coagulant/antiplatelet therapy as per local standard.
- History of a liver disease, bleeding disorder, coagulopathy or a history of spontaneous hemorrhage or evidence of increased risk of bleeding
- Abnormal coagulation profile (Platelets < 80,000), PT (>14) or PTT (>36), and INR > 1.3.
- Large lacunar lesions that cannot be navigated around
- 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 week) which could be worsened by disruption of the blood brain barrier
- History of anaphylactic shock
- Active 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
- Any contraindications to MRI scanning,
- Impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2
- Severe Respiratory Illness
- Currently in a clinical trial involving an investigational product or non-approved use of a drug or device
- Pregnancy or Lactation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland
Baltimore, Maryland, 21201
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Pivotal Study to Evaluate the Safety and Effectiveness of Exablate Model 4000 Using Microbubble Resonators to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma
The purpose of this study is to evaluate the safety and effectiveness of using the Exablate Type 2 system using microbubble resonators (Exablate Test Arm) to disrupt the Blood-Brain Barrier for the purpose of temporarily transforming, and thereby 'marking', regions of infiltrating gliomas prior to planned surgical resection, for the purpose of improving tumor visualization during the surgery to achieve a greater proportion of subjects who receive a Gross Total Resection (GTR) per plan compared to those not undergoing a BBBD procedure prior to resection (Control Arm).
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized in a 2:1 ratio to Exablate Test Arm and to Control Arm, respectively. The following assessments will occur:
- Pre-surgical planning and Post-surgical visit MRI exams with and without contrast will be collected for evaluation by the study core lab; Any return to surgery for additional resection will be captured
- All subjects will be seen at ~Week 2, and ~4-Weeks post resection for physical and neurological exams and to assess for complications or adverse events. These visits should coincide with standard (Neuro-oncology) care following resection.
- Long-term outcomes will be collected during standard of care Neuro-oncology care follow-up visits for up to 2 years post resection; standard of care MRIs and RANO assessments will be collected.
- Conditions
- Glioma
- Being tested
- Exablate BBBD
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exablate BBBDDevice
Blood brain barrier disruption using ExAblate Type 2 device using microbubble resonators
| Study group | Role | What they receive |
|---|---|---|
| Exablate Test Arm | Active comparator | Subjects will undergo ExAblate BBBD prior to their standard of care tumor removal Receives: Device: Exablate BBBD |
| Control Test Arm | No intervention | Subjects will undergo their standard of care tumor removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall safety of the Exablate BBBD procedure itself as measured through the collection of adverse events
Safety of the Exablate BBBD procedure will be evaluated by patient examination and post-procedure MRI exams assessing changes in the treated region. Adverse events will be reported by the Investigator and monitored in both treatment arms.
Measured: Approximately 2 months
Effectiveness of BBBD as determined by the proportion of subjects in whom a GTR is acheived
The proportion of subjects in whom a gross total resection (actual versus planned) is achieved as measured on post-operative imaging compared to pre-resection imaging
Measured: MRI 72 hours post resection
Secondary outcomes (2)
Confirmation of accuracy of Exablate BBBD targeting
Confirmation that new BBBD by contrast enhancement in a previously non-enhancing area overlies the intended target for BBBD. (ExAblate arm only)
Measured: MRI immediately after the ExAblate procedure
Return Rate for Second Surgery for Completion of Resection
Comparison of the Return Rate between the two treatment arms.
Measured: Approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start23 Oct 2024
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Why it stopped: Company decision to switch to other trials
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Graeme Woodworth, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667715
- Sponsor's protocol ID
- BT011
- Acronym
- BBBD
- Status last verified
- Apr 2025
- First submitted
- 8 Dec 2020
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study to Evaluate the Safety and Effectiveness of Exablate Model 4000 Using Microbubble Resonators to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma
- ClinicalTrials.gov ID
- NCT04667715
- Acronym / sponsor ID
- BBBD / BT011
- Conditions
- Glioma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision to switch to other trials
- Enrolment
- 0 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 16 Dec 2020 (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 and effectiveness of using the Exablate Type 2 system using microbubble resonators (Exablate Test Arm) to disrupt the Blood-Brain Barrier for the purpose of temporarily transforming, and thereby 'marking', regions of infiltrating gliomas prior to planned surgical resection, for the purpose of improving tumor visualization during the surgery to achieve a greater proportion of subjects who receive a Gross Total Resection (GTR) per plan compared to those not undergoing a BBBD procedure prior to resection (Control Arm).
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized in a 2:1 ratio to Exablate Test Arm and to Control Arm, respectively. The following assessments will occur:
- Pre-surgical planning and Post-surgical visit MRI exams with and without contrast will be collected for evaluation by the study core lab; Any return to surgery for additional resection will be captured
- All subjects will be seen at ~Week 2, and ~4-Weeks post resection for physical and neurological exams and to assess for complications or adverse events. These visits should coincide with standard (Neuro-oncology) care following resection.
- Long-term outcomes will be collected during standard of care Neuro-oncology care follow-up visits for up to 2 years post resection; standard of care MRIs and RANO assessments will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exablate Test Arm | Active comparator | Device: Exablate BBBDSubjects will undergo ExAblate BBBD prior to their standard of care tumor removal |
| Control Test Arm | No intervention | –Subjects will undergo their standard of care tumor removal |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female between 21-85 years of age who are able and willing to give informed consent
- Subjects with suspected Grade II, III or IV infiltrating glioma (IG) on pre-operative brain imaging scans who have a non-enhancing component and are planned for surgical resection.
- Karnofsky Performance Score 70-100
- Able to communicate sensations during the Exablate BBBD procedure
Key exclusion criteria (36 listed)
- Tumor originating from the deep midline, thalamus, midbrain, cerebellum or brainstem.
- Multifocal tumors
- MRI or clinical findings of:
- 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
- MR non-compatible metallic implants in the skull or the brain or the presence of unknown MR unsafe devices
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 |
|---|---|---|
| Exablate BBBDBlood brain barrier disruption using ExAblate Type 2 device using microbubble resonators | Device | Exablate Test Arm |
Primary outcome
Overall safety of the Exablate BBBD procedure itself as measured through the collection of adverse events
Time frame: Approximately 2 months
Safety of the Exablate BBBD procedure will be evaluated by patient examination and post-procedure MRI exams assessing changes in the treated region. Adverse events will be reported by the Investigator and monitored in both treatment arms.
Effectiveness of BBBD as determined by the proportion of subjects in whom a GTR is acheived
Time frame: MRI 72 hours post resection
The proportion of subjects in whom a gross total resection (actual versus planned) is achieved as measured on post-operative imaging compared to pre-resection imaging
2 secondary outcomes
Confirmation of accuracy of Exablate BBBD targeting
Time frame: MRI immediately after the ExAblate procedure
Return Rate for Second Surgery for Completion of Resection
Time frame: Approximately 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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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.
Graeme Woodworth, MD principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exablate BBBD in people with Glioma, run by InSightec at 2 sites in United States.
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 4 inclusion and 36 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: withdrawn, as of the sponsor's last update on 2 May 2025. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Overall safety of the Exablate BBBD procedure itself as measured through the collection of adverse events (time frame: Approximately 2 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 2 May 2025.