Recruiting

Magnetic Resonance Imaging

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT03031873

Conditions

Arteriovenous Malformations

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI perfusion imaging

Study Details

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

Study ID

NCT03031873

Start date

Mar 1, 2020

Status verified date

Jun, 2022

Completion date

Mar, 2024

Anticipated

Primary completion date

Mar, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: 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.

Interventions

MRI perfusion imaging

Evaluate the evolution of progressive obliteration of the AVM nidus

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Howard Lesiuk, MD

613-798-5555hlesiuk@toh.ca

Betty Anne Schwarz, PhD

613-798-5555nimikhael@ohri.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Betty Anne Schwarz, PhD

6137985555baschwarz@toh.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jun 27, 2022

Last verified

Jun, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2022-06-27.