Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cance… (NCT03714243) | Clinical Trial Compass
CompletedNot Applicable
Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cancer Brain Metastases
Canada8 participantsStarted 2019-09-18
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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
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)
* A…
What they're measuring
1
Adverse events
Timeframe: Throughout the study, approximately 10 months.