Evaluation of Susceptibility-weighted Magnetic Resonance Imaging and 4d-time-resolved Magnetic Resonance Angiography in Brain Arteriovenous Malformations
Primary Purpose
Arteriovenous Malformations
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MRI perfusion imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Arteriovenous Malformations
Eligibility Criteria
Inclusion Criteria:
- Informed consent
- Brain AVMs previously diagnosed with either CT Angiography, MRI or catheter angiography.
- Undergoing cerebral catheter angiography for clinical evaluation of the brain AVM. Patients with brain AVMs scheduled for catheter cerebral angiography will undergo MRI (GE 3T) within 3 months.
- Age > 18 years.
- mRS <=2
- Brain AVM visible on MRI, i.e. nidus > 1 cm
Exclusion Criteria:
- Contraindication to MRI eg. Non-MRI compatible implant, severe claustrophobia
- Contraindication for contrast: GFR < 60 ml/min, allergy to contrast
Sites / Locations
- The Ottawa HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MRI perfusion imaging
Arm Description
SWAN imaging on the GE 3 T has been attempted but the preliminary evidence suggest that the images are of low resolution and difficult to interpret. Similarly, early experience with TRMRA suggest poor spatial and temporal resolution using the standard "out-of-the-box" protocols. Thus, there is a significant opportunity to improve SWAN and TRMRA, to evaluate the evolution of progressive obliteration of the AVM nidus. Specifically, this is attractive for brain AVMs that are treated with radiosurgery as MRI is required for clinical grounds for treatment planning purposes.
Outcomes
Primary Outcome Measures
SWAN and TRMRA with catheter angiography will be measured to determine if accuracy of brain MRI for follow-up of treated brain AVM can be improved
Secondary Outcome Measures
Full Information
NCT ID
NCT03031873
First Posted
December 6, 2016
Last Updated
June 23, 2022
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03031873
Brief Title
Evaluation of Susceptibility-weighted Magnetic Resonance Imaging and 4d-time-resolved Magnetic Resonance Angiography in Brain Arteriovenous Malformations
Official Title
Evaluation of Susceptibility-weighted Magnetic Resonance Imaging and 4d-time-resolved Magnetic Resonance Angiography in Brain Arteriovenous Malformations
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Brain arteriovenous malformations are abnormal communications between brain arteries and veins with an intervening tangle of abnormal arteries (nidus). Brain AVMs may be asymptomatic or symptomatic, presenting with acute hemorrhage or neurological symptoms. Brain AVMs that have not bled carry a yearly risk of intracranial hemorrhage of approximately 4% (Ondra et al.).
The management is multidisciplinary involving neurosurgeons, interventional neuroradiologists, radiation physicians, neurologists and allied health care personnel. Patients may be treated with open neurosurgery, endovascular embolization, radiation therapy or any combination of these treatments. The goal of the treatment is to eliminate the brain AVM while preserving normal flow to the surrounding normal arteries. This involves obliteration of the shunting of blood via the AVM arteries to veins by a variety of treatments. The treatment regimen is individualized dependent on natural history, the angioarchitecture, location, risk of treatment(s) and patient wishes.
Detailed Description
Why is MRI important in the management of brain AVMs i.e. over conventional catheter angiography? The "gold standard" for evaluation of brain AVMs is catheter angiography. However, the procedure is invasive, involves ionizing radiation, exposure to contrast media with potential for nephrotoxicity or allergy and carries a 1% risk of morbidity including stroke. In contrast, MRI is a non-invasive method to evaluate brain AVMs and has the added advantage over catheter angiography of depicting the anatomical localization of the AVM within the brain tissue. However, currently MRI is limited by lack of ability to demonstrate shunting of blood through the AVM, an important indicator that the brain AVM is still present after treatment.
Susceptibility-weighted imaging (SWI) is a promising new MRI technology which indirectly evaluates the amount of oxygen within blood vessels. Small case series exploring the utility of SWI in brain AVMs has been reported suggesting the venous drainage of brain AVMs is often abnormally hyperintense because of abnormal shunting of oxygenated blood from AVM arteries to the draining vein(Bharathi D et al.). Typically in normal tissues, oxygenated blood on SWI images is hyperintense while deoxygenated blood in normal veins is hypointense. Developmental venous anomalies demonstrating enlarged draining veins are normal variants that must be distinguished from true AVMs . However, this capability has not been prospectively evaluated in a systematic fashion.
Our current standard for contrast-enhanced evaluation of brain AVMs is to perform a contrast-enhanced MRA (CEMRA) followed by a post-contrast T1 volumetric whole brain sequence. The CEMRA allows depiction of contrast at its maximal intensity passing through the brain on its first pass. The post contrast T1 scan only demonstrates static contrast pooling within the brain AVM. However, neither CEMRA nor the post contrast scan provides information about the speed at which contrast is moving through a brain AVM ie. shunting. Evaluation of the temporal passage of contrast brain AVM would require a dynamic time-resolved technique with adequate temporal resolution to distinguish early vs late vs no shunting within a brain AVM.
What is the current technology for MRI of brain AVMs? Susceptibility-weighted angiography (SWAN) imaging on the GE 3 T has been attempted but the preliminary evidence suggest that the images are of low resolution and difficult to interpret. In addition, our literature review found a paucity of studies evaluating staged treatment of brain AVMs with SWAN imaging. In our institution, brain AVMs may have staged treatment consistent of endovascular embolization and/or radiosurgery. After each treatment patients are followed with serial imaging MRI and Digital Subtraction Angiography (DSA). This provides an important opportunity to investigate the utility of non-invasive MRI to detect residual AVM after treatment.
Thus, there is a significant opportunity to evaluate the value of SWAN and Time Resolved Magnetic Resonance Angiography (TRMRA) assessment of progressive obliteration of the AVM nidus. Specifically, this is attractive for brain AVMs that are treated with radiosurgery as MRI and DSA are required for clinical grounds for treatment planning purposes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Malformations
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MRI perfusion imaging
Arm Type
Other
Arm Description
SWAN imaging on the GE 3 T has been attempted but the preliminary evidence suggest that the images are of low resolution and difficult to interpret. Similarly, early experience with TRMRA suggest poor spatial and temporal resolution using the standard "out-of-the-box" protocols.
Thus, there is a significant opportunity to improve SWAN and TRMRA, to evaluate the evolution of progressive obliteration of the AVM nidus. Specifically, this is attractive for brain AVMs that are treated with radiosurgery as MRI is required for clinical grounds for treatment planning purposes.
Intervention Type
Device
Intervention Name(s)
MRI perfusion imaging
Intervention Description
Evaluate the evolution of progressive obliteration of the AVM nidus
Primary Outcome Measure Information:
Title
SWAN and TRMRA with catheter angiography will be measured to determine if accuracy of brain MRI for follow-up of treated brain AVM can be improved
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent
Brain AVMs previously diagnosed with either CT Angiography, MRI or catheter angiography.
Undergoing cerebral catheter angiography for clinical evaluation of the brain AVM. Patients with brain AVMs scheduled for catheter cerebral angiography will undergo MRI (GE 3T) within 3 months.
Age > 18 years.
mRS <=2
Brain AVM visible on MRI, i.e. nidus > 1 cm
Exclusion Criteria:
Contraindication to MRI eg. Non-MRI compatible implant, severe claustrophobia
Contraindication for contrast: GFR < 60 ml/min, allergy to contrast
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Howard Lesiuk, MD
Phone
613-798-5555
Ext
17522
Email
hlesiuk@toh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Betty Anne Schwarz, PhD
Phone
613-798-5555
Ext
17520
Email
nimikhael@ohri.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Lesiuk, MD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Betty Anne Schwarz, PhD
Phone
6137985555
Ext
17522
Email
baschwarz@toh.ca
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Susceptibility-weighted Magnetic Resonance Imaging and 4d-time-resolved Magnetic Resonance Angiography in Brain Arteriovenous Malformations
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