Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cancer Brain Metastases

NCT03714243 | Completed DMC

• 2 other identifiers: BT006277990
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Brain Metastases

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Rate of adverse events following each treatment through end of study

  Throughout the study, approximately 10 months.

Secondary Outcomes (1)

• Feasibility of BBBD

  Immediately after each BBBD procedure

Study Arms (1)

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

Device: ExAblate BBBD

Interventions

ExAblate BBBD DEVICE

Using ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in patients with Her-2 positive breast cancer and brain metastases

Also known as: Exablate Neuro

ExAblate BBBD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nir Lipsman, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single arm, single center

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 22, 2018
• Study Start: September 18, 2019
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CA (1)