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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03714243
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
InSightec

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Brain Metastases Device: ExAblate BBBD Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, single arm, single center
Masking: None (Open Label)
Primary Purpose: Device Feasibility
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
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: ExAblate BBBD
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
Using ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in patients with Her-2 positive breast cancer and brain metastases
Other Name: Exablate Neuro


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events [ Time Frame: Throughout the study, approximately 10 months. ]
    Rate of adverse events following each treatment through end of study


Secondary Outcome Measures :
  1. Feasibility of BBBD [ Time Frame: Immediately after each BBBD procedure ]
    The extent of BBB opening will be determined by the degree of contrast enhancement seen on post-procedure MRI with contrast agent


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714243


Contacts
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Contact: Lisa Dye 7742666280 lisad@insightec.com

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Maheleth Llinus    416-480-6100 ext 2476    maheleth.llinas@sunnybrook.ca   
Principal Investigator: Nir Lipsman, MD         
Sponsors and Collaborators
InSightec
Investigators
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Principal Investigator: Nir Lipsman, MD Sunnybrook Health Sciences Centre
More Information
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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT03714243    
Other Study ID Numbers: BT006
277990 ( Other Identifier: Health Canada )
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases