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

NCT03031873 | Unknown

• 1 other identifier: 3T MRI evaluation
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriovenous Malformations

Outcome Measures

Primary Outcomes (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

  24 months

Study Arms (1)

MRI perfusion imaging

OTHER

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

Interventions

MRI perfusion imaging DEVICE

Evaluate the evolution of progressive obliteration of the AVM nidus

MRI perfusion imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

RECRUITING

MeSH Terms

Conditions

Arteriovenous Malformations

Interventions

Perfusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Howard Lesiuk, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Howard Lesiuk, MD

CONTACT

613-798-5555; hlesiuk@toh.ca

Betty Anne Schwarz, PhD

CONTACT

613-798-5555; nimikhael@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: January 26, 2017
• Study Start: March 1, 2020
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

CA (1)