Eligibility Details:
Inclusion Criteria:
- 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
- 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
- Any previous systemic treatments are allowed, but a time interval of 1-3 weeks should
have passed since the last treatment
Exclusion Criteria:
- Brain metastases not visible on the pre-therapy imaging
- The sonication pathway to the tumour involves:
i. 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:
i. 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
- 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
- Insulin-dependent diabetes mellitus
- Known allergy sensitivity or contraindications to gadolinium-diethylenetriamine
penta-acetic acid (DTPA), CT contrast, or perflutren
- 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
common.study.methods.has-drugs-no
common.study.methods.is-healthy-yes
