- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02343991
Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- SunnyBrook Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transcranial ExAblate
MR Guided Focused Ultrasound
|
MR Guided Focused Ultrasound
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At the time of ExAblate transcranial procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At the time of ExAblate transcranial procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BBB001
- 215600 (Other Identifier: Health Canada)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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