Brain TumorNCT02343991
Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound
A study testing Transcranial ExABlate in people with Brain Tumor, run by InSightec at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the safety of BBB disruption using transcranial MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent to increase the accumulation of doxorubicin in brain tumours and the adjacent brain using the ExAblate Transcranial system (220 kHz). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Transcranial ExABlate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women.
- Age between 18 and 70 years, inclusive.
- Able and willing to give informed consent.
- Size of the targeted portion of the tumour (i.e. prescribed ROT) is less than 2.5 cm in diameter (16 cm3). The non-targeted tumour tissue may exceed the targeted volume.
- Karnofsky rating 70-100
- ASA score 1-3.
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- Able to communicate sensations during the ExAblate MRgFUS procedure.
- Able to attend all study visits (i.e., life expectancy of at least 3 months).
- At least 14 days passed since last brain surgery.
Who cannot join
- The sonication pathway to the tumour involves:
- 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 ii. Clips or other metallic implanted objects in the skull or the brain, except shunts
- The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema)
- Cardiac disease or unstable hemodynamics including:
- Documented myocardial infarction within six months of enrolment ii. Unstable angina on medication iii. Congestive heart failure iv. Left ventricular ejection fraction below the lower limit of normal v. History of a hemodynamically unstable cardiac arrythmia vi. Cardiac pacemaker
- Severe hypertension (diastolic BP > 100 on medication)
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- Anti-coagulant therapy, or medications known to increase risk of hemorrhage, (e.g.:ASA, non-steroidal anti-inflammatory drugs (NSAIDs), statins)
- History of a bleeding disorder, coagulopathy or with a history of spontaneous tumour hemorrhage
- Abnormal level of platelets (< 100000), PT (>14) or PTT (>36), and INR > 1.3
- Documented cerebral infarction within the past 12 months
- TIA in the last 1 month
- Cerebral or systemic vasculopathy
- Insulin-dependent diabetes mellitus
- Immunosuppression (corticosteroids to prevent/treat brain edema are permitted)
- Known sensitivity to gadolinium-DTPA
- Contraindications to MRI such as non-MRI-compatible implanted devices
- Large subjects not fitting comfortably into the MRI scanner (generally >250 lbs)
- Difficulty lying supine and still for up to 4 hours in the MRI unit or claustrophobia
- Untreated, uncontrolled sleep apnea
- Positive pregnancy test (for pre-menopausal women)
- Known life-threatening systemic disease
- Severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2 and/or on dialysis
- Right to left or bi-directional cardiac shunt
- Previous full course of doxorubicin chemotherapy
- Allergy to eggs or egg products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Safety and Feasibility of Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound With Intravenous Ultrasound Contrast Agents in the Treatment of Brain Tumours With Doxorubicin
The purpose of this study is to evaluate the safety of BBB disruption using transcranial MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent to increase the accumulation of doxorubicin in brain tumours and the adjacent brain using the ExAblate Transcranial system (220 kHz). Data will be collected to establish the basic safety of this type of treatment as the basis for later studies to evaluate its clinical efficacy.
- Conditions
- Brain Tumor
- Being tested
- Transcranial ExABlate
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial ExABlateDevice
Also called ExAblate, TcMRgFUS
MR Guided Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Transcranial ExAblate | Experimental | MR Guided Focused Ultrasound Receives: Device: Transcranial ExABlate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Device and Procedure Related Adverse Events
To evaluate the total number of adverse events (AEs) associated with the ExAblate transcranial treatment and procedure.
Measured: At the time of ExAblate transcranial procedure (Visit 2: Treatment Day) until patient completion (Visit 5: 3 months post treatment)
Number of Severe Device and Procedure Related Adverse Events
To evaluate the number of severe adverse events (AEs) associated with the ExAblate transcranial device and procedure
Measured: At the time of ExAblate transcranial procedure (Visit 2: Treatment Day) until patient completion (Visit 5: 3 months post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2024
- Study completionOct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343991
- Sponsor's protocol ID
- BBB001
- Other IDs
- 215600
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2015
- Last updated
- 19 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mainprize T, Lipsman N, Huang Y, Meng Y, Bethune A, Ironside S, Heyn C, Alkins R, Trudeau M, Sahgal A, Perry J, Hynynen K. Blood-Brain Barrier Opening in Primary Brain Tumors with Non-invasive MR-Guided Focused Ultrasound: A Clinical Safety and Feasibility Study. Sci Rep. 2019 Jan 23;9(1):321. doi: 10.1038/s41598-018-36340-0.
PubMed 30674905
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Feasibility of Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound With Intravenous Ultrasound Contrast Agents in the Treatment of Brain Tumours With Doxorubicin
- ClinicalTrials.gov ID
- NCT02343991
- Acronym / sponsor ID
- BBB001
- Conditions
- Brain Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2024 (actual)
- Study completion
- Oct 2024 (actual)
- First posted
- 22 Jan 2015 (estimated)
- Results
- Posted 19 Oct 2026
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 BBB disruption using transcranial MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent to increase the accumulation of doxorubicin in brain tumours and the adjacent brain using the ExAblate Transcranial system (220 kHz). Data will be collected to establish the basic safety of this type of treatment as the basis for later studies to evaluate its clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial ExAblate | Experimental | Device: Transcranial ExABlateMR Guided Focused Ultrasound |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women.
- Age between 18 and 70 years, inclusive.
- Able and willing to give informed consent.
- Size of the targeted portion of the tumour (i.e. prescribed ROT) is less than 2.5 cm in diameter (16 cm3). The non-targeted tumour tissue may exceed the targeted volume.
- Karnofsky rating 70-100
Key exclusion criteria (25 listed)
- The sonication pathway to the tumour involves:
- The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema)
- Cardiac disease or unstable hemodynamics including:
- Severe hypertension (diastolic BP > 100 on medication)
- Anti-coagulant therapy, or medications known to increase risk of hemorrhage, (e.g.:ASA, non-steroidal anti-inflammatory drugs (NSAIDs), statins)
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 |
|---|---|---|
| Transcranial ExABlateAlso: ExAblate, TcMRgFUSMR Guided Focused Ultrasound | Device | Transcranial ExAblate |
Primary outcome
Total Number of Device and Procedure Related Adverse Events
Time frame: At the time of ExAblate transcranial procedure (Visit 2: Treatment Day) until patient completion (Visit 5: 3 months post treatment)
To evaluate the total number of adverse events (AEs) associated with the ExAblate transcranial treatment and procedure.
Number of Severe Device and Procedure Related Adverse Events
Time frame: At the time of ExAblate transcranial procedure (Visit 2: Treatment Day) until patient completion (Visit 5: 3 months post treatment)
To evaluate the number of severe adverse events (AEs) associated with the ExAblate transcranial device and procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30674905Mainprize T, Lipsman N, Huang Y, Meng Y, Bethune A, Ironside S, Heyn C, Alkins R, Trudeau M, Sahgal A, Perry J, Hynynen K. Blood-Brain Barrier Opening in Primary Brain Tumors with Non-invasive MR-Guided Focused Ultrasound: A Clinical Safety and Feasibility Study. Sci Rep. 2019 Jan 23;9(1):321. doi: 10.1038/s41598-018-36340-0.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial ExABlate in people with Brain Tumor, run by InSightec at 1 site in Canada.
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 9 inclusion and 25 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Yes. Results are posted in the registry (first posted 19 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Number of Device and Procedure Related Adverse Events (time frame: At the time of ExAblate transcranial procedure (Visit 2: Treatment Day) until patient completion (Visit 5: 3 months post treatment)). 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?
On the ClinicalTrials.gov record for NCT02343991, which also lists 1 linked publication.
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 19 Oct 2026.