- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02896881
Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations (MAV-IRM)
Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations (MAV-IRM)
Study Overview
Status
Conditions
Detailed Description
Cerebral arteriovenous malformations are treated to eliminate the potential risk of haemorrhage. There are three possible treatment modalities: surgery, radiosurgery or embolisation. Complete exclusion of the arteriovenous malformation is a prerequisite for confirming that there is no residual risk of haemorrhage. After treatment, arteriography is the gold standard for confirming this exclusion. The absence of early opacification of the venous drainage is considered a sign of cure.
Several arteriographic aspects are possible after treatment by embolisation:
- Arteriography may be strictly normal (no abnormalities).
- The persistence of early venous opacification (presence of arterialised blood) indicates the persistence of a residual AVM.
- Other vascular anomalies without early venous drainage may be present: dysplastic vessels (irregular shape, "corkscrew" appearance) ; capillary blush in the embolisation bed (hyperaemia) ; other: slow flow, slow filling, or widening of afferent arteries.
Our previous studies exploring the use of specific MRI sequences, in magnetic susceptibility (SWI), arterial spin labelling (ASL) and angiography (static or dynamic) sequences, have enabled us to demonstrate the very high sensitivity of these sequences for detecting an arteriovenous shunt, whether native (when the AVM is discovered) or residual after treatment. We would like to carry out a prospective study to compare cerebral arteriography and MRI (multi-sequence) in patients treated by embolisation for cerebral arteriovenous malformation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75019
- Fondation Opthalmologique A de Rothschild
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient ≥ 18 years old
- with brain Arteriovenous Malformations
- embolization treatment scheduled
Exclusion Criteria:
- patient's refusal to participate in the study
- contraindication to undergo MRI examination
- patient under legal protection
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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sensitivity of multisequence MRI to detect a residual arteriovenous malformation after embolization
Time Frame: within 3 months after embolization
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Early opacification of a vein, possibly associated with the presence of abnormal vessels, will be sought, indicating a residual malformation.
After interpretation of the MRI (angio-MRI with multi-sequences, magnetic susceptibility (SWI), arterial spin labelling (ASL) and static or dynamic angiography), the result will be coded dichotomously: (presence/absence of a residual malformation).
The arteriography result will be coded in the same way.
The sensitivity of the new MRI sequences for detecting a residual arteriovenous malformation after treatment by embolisation will thus be assessed, compared with arteriography (gold-standard).
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within 3 months after embolization
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Collaborators and Investigators
Investigators
- Principal Investigator: Raphaël Blanc, MD, Fondation Ophtalmologique Adolphe de Rothschild
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBC_2016_7
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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