Arteriovenous MalformationsNCT03031873
Evaluation of Susceptibility-weighted Magnetic Resonance Imaging and 4d-time-resolved Magnetic Resonance Angiography in Brain Arteriovenous Malformations
A study testing MRI perfusion imaging in people with Arteriovenous Malformations, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Malformations
- What is being tested?
- MRI perfusion imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2020to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication to MRI eg. Non-MRI compatible implant, severe claustrophobia
- Contraindication for contrast: GFR < 60 ml/min, allergy to contrast
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Betty Anne Schwarz, PhD, 6137985555 ext. 17522, baschwarz@toh.ca
About this study
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.
Read the 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.
- Conditions
- Arteriovenous Malformations
- Being tested
- MRI perfusion imaging
- Medical subject headings
- Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI perfusion imagingDevice
Evaluate the evolution of progressive obliteration of the AVM nidus
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MRI perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start1 Mar 2020
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous MalformationsStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Lesiuk, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031873
- Sponsor's protocol ID
- 3T MRI evaluation
- Status last verified
- Jun 2022
- First submitted
- 6 Dec 2016
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Susceptibility-weighted Magnetic Resonance Imaging and 4d-time-resolved Magnetic Resonance Angiography in Brain Arteriovenous Malformations
- ClinicalTrials.gov ID
- NCT03031873
- Acronym / sponsor ID
- 3T MRI evaluation
- Conditions
- Arteriovenous Malformations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI perfusion imaging | Other | Device: MRI perfusion imagingSWAN 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindication to MRI eg. Non-MRI compatible implant, severe claustrophobia
- Contraindication for contrast: GFR < 60 ml/min, allergy to contrast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI perfusion imagingEvaluate the evolution of progressive obliteration of the AVM nidus | Device | MRI perfusion imaging |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Lesiuk, MD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI perfusion imaging in people with Arteriovenous Malformations, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Howard Lesiuk, MD (613-798-5555 ext. 17522, hlesiuk@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.