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Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02343991
Recruitment Status : Active, not recruiting
First Posted : January 22, 2015
Last Update Posted : January 10, 2019
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 transcranial MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent to increase the accumulation of doxorubicin in brain tumours and the adjacent brain using the ExAblate Transcranial system (220 kHz). Data will be collected to establish the basic safety of this type of treatment as the basis for later studies to evaluate its clinical efficacy.

Condition or disease Intervention/treatment Phase
Brain Tumor Device: Transcranial ExABlate Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Safety and Feasibility of Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound With Intravenous Ultrasound Contrast Agents in the Treatment of Brain Tumours With Doxorubicin
Study Start Date : October 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Transcranial ExAblate
MR Guided Focused Ultrasound
 Device: Transcranial ExABlate
MR Guided Focused Ultrasound
Other Names:
  • ExAblate
  • TcMRgFUS


Outcome Measures
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Primary Outcome Measures :
  1. Number of Device and Procedure related adverse events [ Time Frame: At the time of ExAblate transcranial procedure ]
    To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate transcranial treatment


Secondary Outcome Measures :
  1. Severity of Device and Procedure related adverse events [ Time Frame: At the time of ExAblate transcranial procedure ]
    To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate transcranial treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women.
  • Age between 18 and 70 years, inclusive.
  • Able and willing to give informed consent.
  • Size of the targeted portion of the tumour (i.e. prescribed ROT) is less than 2.5 cm in diameter (16 cm3). The non-targeted tumour tissue may exceed the targeted volume.
  • Karnofsky rating 70-100
  • ASA score 1-3.
  • Able to communicate sensations during the ExAblate MRgFUS 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.

Exclusion Criteria:

  • The sonication pathway to the tumour involves:

    i. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp 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 below the lower limit of normal v. History of a hemodynamically unstable cardiac arrythmia vi. Cardiac pacemaker

  • Severe hypertension (diastolic BP > 100 on medication)
  • Anti-coagulant therapy, or medications known to increase risk of hemorrhage, (e.g.:ASA, non-steroidal anti-inflammatory drugs (NSAIDs), statins)
  • History of a bleeding disorder, coagulopathy or with a history of spontaneous tumour hemorrhage
  • Abnormal level of platelets (< 100000), PT (>14) or PTT (>36), and INR > 1.3
  • Documented cerebral infarction within the past 12 months
  • TIA in the last 1 month
  • Cerebral or systemic vasculopathy
  • Insulin-dependent diabetes mellitus
  • Immunosuppression (corticosteroids to prevent/treat brain edema are permitted)
  • Known sensitivity to gadolinium-DTPA
  • 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 with estimated glomerular filtration rate <30 mL/min/1.73m2 and/or on dialysis
  • Right to left or bi-directional cardiac shunt
  • Previous full course of doxorubicin chemotherapy
  • Allergy to eggs or egg products
Contacts and Locations
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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): NCT02343991


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
InSightec
More Information
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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT02343991     History of Changes
Other Study ID Numbers: BBB001
215600 ( Other Identifier: Health Canada )
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases