Breast CancerBBBDNCT03714243
Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cancer Brain Metastases
A study testing ExAblate BBBD in people with Breast Cancer and Brain Metastases, run by InSightec at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the safety of BBB disruption using the ExAblate 4000-system Type 2 in patients with Her-2 positive breast cancer metastases in the brain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer, Brain Metastases
- 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
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 18 Sep 2019to 28 Apr 2022
- 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
- Men and women between 18 and 80 years of age
- Able and willing to give informed consent
- Metastatic Her2-positive breast cancer with brain metastases
- Karnofsky performance score 70-100
- ASA score 1-3
- Able to communicate sensations during the ExAblate BBBD procedure
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- Able to attend all study visits (i.e., life expectancy of at least 3 months)
- At least 14 days passed since last brain surgery
- At least 6 weeks passed since last radiation treatment
Who cannot join
- Brain metastases not visible on the pre-therapy imaging
- The sonication pathway to the tumour involves:
- Extensive scalp scars 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 < 50% v. Right-to-left, bidirectional, or transient right-to-left cardiac shunts vi. History of a hemodynamically unstable cardiac arrythmia vii. Cardiac pacemaker viii. Contraindications to perflutren including subjects with a family or personal history of QT prolongation or taking concomitant medications known to cause QTc prolongation
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- Severe hypertension (diastolic BP > 100 on medication)
- Anti-coagulant therapy or 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 a bleeding disorder, coagulopathy or with a history of spontaneous tumour hemorrhage
- Abnormal level of platelets (< 100000) or INR > 1.3
- Documented cerebral infarction within the past 12 months
- Transient Ischemic Attack (TIA) in the last 1 month
- Known allergy sensitivity or contraindications to gadolinium-diethylenetriamine penta-acetic acid (DTPA), CT contrast, or perflutren or trastuzumab
- Allergy to eggs or egg products
- 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
- Respiratory: chronic pulmonary disorders, e.g. severe emphysema, chronic obstructive pulmonary disease (COPD), pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area, subjects with a history of drug allergies
- Any illness or medical condition that in the investigator's opinion precludes participation in this study
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 MRI-Guided Focused Ultrasound in the Treatment of Her2-positive Breast Cancer Brain Metastases
The purpose of this study is to evaluate the safety of BBB disruption using the ExAblate 4000-system Type 2 in patients with Her-2 positive breast cancer metastases in the brain.
Read the detailed description
The goal of this prospective, single arm, non-randomized study is to evaluate the safety and feasibility of using the Exablate Model 4000 Type 2 "Neuro-System" as a tool to serially disrupt the blood brain barrier in a temporary and localized fashion in patients with breast cancer and brain metastases. Up to 10 patients will be recruited at Sunnybrook. Patients will be consented, screened, undergo up to 6 study Exablate BBBD treatment cycles, every 2-3 weeks based on their trastuzumab regimen. Follow-up will continue through 12 weeks following the last BBBD post-treatment and the subject's participation in the study will be complete.
Data will be collected to establish the basic safety of this type of treatment as the basis for later studies to evaluate clinical efficacy.
- Conditions
- Breast Cancer, Brain Metastases
- Being tested
- ExAblate BBBD
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate BBBDDevice
Also called Exablate Neuro
Using ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in patients with Her-2 positive breast cancer and brain metastases
| Study group | Role | What they receive |
|---|---|---|
| ExAblate BBBD | Experimental | Using ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in patients with Her-2 positive breast cancer and brain metastases Receives: Device: ExAblate BBBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Rate of adverse events following each treatment through end of study
Measured: Throughout the study, approximately 10 months.
Secondary outcomes (1)
Feasibility of BBBD
The extent of BBB opening will be determined by the degree of contrast enhancement seen on post-procedure MRI with contrast agent
Measured: Immediately after each BBBD procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start18 Sep 2019
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single arm, single center
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nir Lipsman, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714243
- Sponsor's protocol ID
- BT006
- Other IDs
- 277990
- Acronym
- BBBD
- Status last verified
- Mar 2026
- First submitted
- 17 Oct 2018
- Last updated
- 20 Mar 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 20 Mar 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 MRI-Guided Focused Ultrasound in the Treatment of Her2-positive Breast Cancer Brain Metastases
- ClinicalTrials.gov ID
- NCT03714243
- Acronym / sponsor ID
- BBBD / BT006
- Conditions
- Breast Cancer, Brain Metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 22 Oct 2018 (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 BBB disruption using the ExAblate 4000-system Type 2 in patients with Her-2 positive breast cancer metastases in the brain.
Detailed description
The goal of this prospective, single arm, non-randomized study is to evaluate the safety and feasibility of using the Exablate Model 4000 Type 2 "Neuro-System" as a tool to serially disrupt the blood brain barrier in a temporary and localized fashion in patients with breast cancer and brain metastases. Up to 10 patients will be recruited at Sunnybrook. Patients will be consented, screened, undergo up to 6 study Exablate BBBD treatment cycles, every 2-3 weeks based on their trastuzumab regimen. Follow-up will continue through 12 weeks following the last BBBD post-treatment and the subject's participation in the study will be complete.
Data will be collected to establish the basic safety of this type of treatment as the basis for later studies to evaluate clinical efficacy.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single arm, single center
| Arm | Type | Receives |
|---|---|---|
| ExAblate BBBD | Experimental | Device: ExAblate BBBDUsing ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in patients with Her-2 positive breast cancer and brain metastases |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women between 18 and 80 years of age
- Able and willing to give informed consent
- Metastatic Her2-positive breast cancer with brain metastases
- Karnofsky performance score 70-100
- ASA score 1-3
Key exclusion criteria (23 listed)
- Brain metastases not visible on the pre-therapy imaging
- 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)
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 BBBDAlso: Exablate NeuroUsing ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in patients with Her-2 positive breast cancer and brain metastases | Device | ExAblate BBBD |
Primary outcome
Adverse events
Time frame: Throughout the study, approximately 10 months.
Rate of adverse events following each treatment through end of study
1 secondary outcome
Feasibility of BBBD
Time frame: Immediately after each BBBD procedure
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 20 Mar 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.
Nir Lipsman, MD principal investigator
Sunnybrook Health Sciences Centre
1 site 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 Breast Cancer and Brain Metastases, 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 23 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 20 Mar 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?
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: Throughout the study, approximately 10 months.). 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 20 Mar 2026.