Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Susceptibility-weighted Magnetic Resonance Imaging and 4d-time-resolved Magnetic Resonance Angiography in Brain Arteriovenous Malformations

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: NCT03031873
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.


Condition or disease Intervention/treatment Phase
Arteriovenous Malformations Device: MRI perfusion imaging Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Susceptibility-weighted Magnetic Resonance Imaging and 4d-time-resolved Magnetic Resonance Angiography in Brain Arteriovenous Malformations
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
MRI perfusion imaging

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.

Device: MRI perfusion imaging
Evaluate the evolution of progressive obliteration of the AVM nidus




Primary Outcome Measures :
  1. 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 ]


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent
  2. Brain AVMs previously diagnosed with either CT Angiography, MRI or catheter angiography.
  3. 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.
  4. Age > 18 years.
  5. mRS <=2
  6. Brain AVM visible on MRI, i.e. nidus > 1 cm

Exclusion Criteria:

  1. Contraindication to MRI eg. Non-MRI compatible implant, severe claustrophobia
  2. Contraindication for contrast: GFR < 60 ml/min, allergy to contrast

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): NCT03031873


Contacts
Layout table for location contacts
Contact: Howard Lesiuk, MD 613-798-5555 ext 17522 hlesiuk@toh.ca
Contact: Betty Anne Schwarz, PhD 613-798-5555 ext 17520 nimikhael@ohri.ca

Locations
Layout table for location information
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Betty Anne Schwarz, PhD    6137985555 ext 17522    baschwarz@toh.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Howard Lesiuk, MD Ottawa Hospital Research Institute
Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03031873    
Other Study ID Numbers: 3T MRI evaluation
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemangioma
Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms