GlioblastomaNCT05383872
Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors
A study testing Focused Ultrasound (Exablate Model 4000) in people with Glioblastoma and Glioma, run by InSightec at 17 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for liquid biopsy in subjects with suspected Glioblastoma brain tumors Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioblastoma, Glioma, Liquid Biopsy
- What is being tested?
- Focused Ultrasound (Exablate Model 4000)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 8 Aug 2022to 5 Mar 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female subjects18-80 years of age who are able and willing to give informed consent, or whose legally authorized representative is willing to consent on their behalf
- Subjects with stereotactically-targetable suspected new or recurrent glioblastoma tumor on pre-operative brain imaging scans
- Subjects that are scheduled, or will be scheduled within 4 weeks, for surgical resection or biopsy per standard clinical tumor care
- Karnofsky Performance Score >70
- Able to communicate sensations during the Exablate BBBD procedure
Who cannot join
- Subjects with inoperable tumors (e.g., tumor originating from the deep midline, thalamus, midbrain, cerebellum or brainstem)
- Multifocal tumors
- Tumor morphology or other imaging findings that precludes the ability to sonicate the tumor volume (including significant tumor volume outside the treatment envelope or tumor volume that exceeds the maximum sonication volume allowed, i.e. currently 110 ccs at the treatment volume level). Concern for adequate tumor coverage by sonication based on tumor morphology should be discussed with the Sponsor.
- 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
Show all 33Show fewer
- Intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis
- 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
- Documented left ventricular ejection fraction below the lower limit of normal
- History of a hemodynamically unstable cardiac arrhythmia
- Cardiac pacemaker
- Uncontrolled hypertension (systolic > 180 and diastolic BP > 120 on medication)
- Undergoing anti-coagulant or anti-platelet therapy, or using medications known to increase risk of hemorrhage within washout period prior to treatment (i.e., antiplatelet or vitamin K inhibitor anticoagulants within 7 days, non-vitamin K inhibitor anticoagulants within 72 hours, or heparin-derived compounds within 48 hours of treatment).
- History of bleeding disorder, coagulopathy or a history of spontaneous hemorrhage or evidence of increased risk of bleeding
- Abnormal coagulation profile (Platelets < 80,000, PT >14, PTT >36, or INR > 1.3)
- Known cerebral or systemic vasculopathy
- Significant depression and at potential risk of suicide
- Known sensitivity/allergy to gadolinium or DEFINITY/DEFINITY RT,
- Active seizures despite medication treatment (defined as >1 seizure per week) which could be worsened by disruption of the blood brain barrier
- Active drug or alcohol disorder which have a higher risk for seizures, infection and/or poor executive functioning
- Known 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, including:
- Large subjects not fitting comfortably into the scanner
- Difficulty lying supine and still for up to 3 hours in the MRI unit or claustrophobia
- Impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2
- Severe Respiratory Illness: chronic pulmonary disorders (e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area), subjects with a history of severe drug allergies, severe asthma or hay fever, or multiple allergies where the benefit/risk of administering DEFINITY/DEFINITY RT is considered unfavorable by the study physicians in relation to the product labeling for DEFINITY/DEFINITY RT
- 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
17 sites in 2 countries.
17 sites in 2 countries
United States16 sites
University of Maryland, Baltimore & The University of Maryland Medical System
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21218
University of North Carolina
Chapel Hill, North Carolina, 27516
University of Texas, Southwestern
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
UF Health Shands Hospital
Gainesville, Florida, 32608
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of California, Los Angeles
Los Angeles, California, 90095
Miami Cancer Institute at Baptist Health
Miami, Florida, 33176
West Virginia University Rockefeller Neuroscience Center
Morgantown, West Virginia, 26506
NYU Grossman School of Medicine
New York, New York, 10016
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92618
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Francisco
San Francisco, California, 94107
Tampa General Hospital
Tampa, Florida, 33606
Moffitt Cancer Center
Tampa, Florida, 33612
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) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for liquid biopsy in subjects with suspected Glioblastoma brain tumors
Read the detailed description
This is a prospective, multi-center, pivotal clinical trial to evaluate the safety and efficacy of targeted blood brain barrier disruption using Exablate Model 4000 Type 2 for liquid biopsy in subjects with suspected Glioblastoma brain tumors. The study will be conducted at up to 25 centers in the US.
- Conditions
- Glioblastoma, Glioma, Liquid Biopsy
- Being tested
- Focused Ultrasound (Exablate Model 4000)
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Ultrasound (Exablate Model 4000)Device
BBB opening via Exablate Type 2 system with microbubble resonators and drawing blood before and after opening
| Study group | Role | What they receive |
|---|---|---|
| Exablate BBBD | Experimental | Using Exablate Model 4000 Type 2 for liquid biopsy in subjects with Glioblastoma Receives: Device: Focused Ultrasound (Exablate Model 4000) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE
Measured: Through study completion, up to 1 year
Correlation with Tumor Tissue
To demonstrate there is a correlation between patterns obtained in the panel of biomarkers evaluated in the resected tumor tissue and/or biopsy and blood sample collected post-BBBD
Measured: Up to 3 hours Post-BBBD
Secondary outcomes (1)
Circulating Free DNA
To demonstrate that there is at least a 2-fold increase in circulating free DNA following blood brain barrier disruption (BBBD)
Measured: Up to 3 hours Post-BBBD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start8 Aug 2022
- Primary completion21 Feb 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383872
- Sponsor's protocol ID
- BT015
- Status last verified
- Jul 2025
- First submitted
- 25 Apr 2022
- Last updated
- 28 Jul 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 28 Jul 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) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors
- ClinicalTrials.gov ID
- NCT05383872
- Acronym / sponsor ID
- BT015
- Conditions
- Glioblastoma, Glioma, Liquid Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 20 May 2022 (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 efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for liquid biopsy in subjects with suspected Glioblastoma brain tumors
Detailed description
This is a prospective, multi-center, pivotal clinical trial to evaluate the safety and efficacy of targeted blood brain barrier disruption using Exablate Model 4000 Type 2 for liquid biopsy in subjects with suspected Glioblastoma brain tumors. The study will be conducted at up to 25 centers in the US.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exablate BBBD | Experimental | Device: Focused Ultrasound (Exablate Model 4000)Using Exablate Model 4000 Type 2 for liquid biopsy in subjects with Glioblastoma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female subjects18-80 years of age who are able and willing to give informed consent, or whose legally authorized representative is willing to consent on their behalf
- Subjects with stereotactically-targetable suspected new or recurrent glioblastoma tumor on pre-operative brain imaging scans
- Subjects that are scheduled, or will be scheduled within 4 weeks, for surgical resection or biopsy per standard clinical tumor care
- Karnofsky Performance Score >70
- Able to communicate sensations during the Exablate BBBD procedure
Key exclusion criteria (33 listed)
- Subjects with inoperable tumors (e.g., tumor originating from the deep midline, thalamus, midbrain, cerebellum or brainstem)
- Multifocal tumors
- Tumor morphology or other imaging findings that precludes the ability to sonicate the tumor volume (including significant tumor volume outside the treatment envelope or tumor volume that exceeds the maximum sonication volume allowed, i.e. currently 110 ccs at the treatment volume level). Concern for adequate tumor coverage by sonication based on tumor morphology should be discussed with the Sponsor.
- MRI or clinical findings of:
- 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 |
|---|---|---|
| Focused Ultrasound (Exablate Model 4000)BBB opening via Exablate Type 2 system with microbubble resonators and drawing blood before and after opening | Device | Exablate BBBD |
Primary outcome
Adverse Events
Time frame: Through study completion, up to 1 year
All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE
Correlation with Tumor Tissue
Time frame: Up to 3 hours Post-BBBD
To demonstrate there is a correlation between patterns obtained in the panel of biomarkers evaluated in the resected tumor tissue and/or biopsy and blood sample collected post-BBBD
1 secondary outcome
Circulating Free DNA
Time frame: Up to 3 hours Post-BBBD
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 28 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Ultrasound (Exablate Model 4000) in people with Glioblastoma and Glioma, run by InSightec at 17 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 5 inclusion and 33 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 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada. 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?
Adverse Events (time frame: Through study completion, up to 1 year). 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 28 Jul 2025.