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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 : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
InSightec

Tracking Information
First Submitted Date  ICMJE October 17, 2018
First Posted Date  ICMJE October 22, 2018
Last Update Posted Date April 21, 2020
Actual Study Start Date  ICMJE September 18, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
Adverse events [ Time Frame: Throughout the study, approximately 3 months. ]
Rate of adverse events following each treatment through end of study
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cancer Brain Metastases
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, single arm, single center
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Breast Cancer
  • Brain Metastases
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Device: ExAblate BBBD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Traci Brooks 469-607-0484 tracib@insightec.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03714243
Other Study ID Numbers  ICMJE BT006
277990 ( Other Identifier: Health Canada )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InSightec
Study Sponsor  ICMJE InSightec
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nir Lipsman, MD Sunnybrook Health Sciences Centre
PRS Account InSightec
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP