Clinical trial NCT02896881: Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations
Official title: Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations (MAV-IRM)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Arteriovenous Malformations
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-12
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with brain Arteriovenous Malformations and embolization treatment scheduled.

Brief summary: In previous studies exploring specific sequences of MRI (susceptibility weighted imaging (SWI) and arterial spin labeling (ASL)), the investigators have shown the great sensibility of these MRI sequences to detect arteriovenous shunts, compared to angiography imaging (static or dynamic). This prospective study aims to compare multisequence MRI to brain arteriography imaging in patients undergoing brain arteriovenous malformations embolization.

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.

Eligibility criteria: 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

Primary outcomes:
measure: sensitivity of multisequence MRI to detect a residual arteriovenous malformation after embolization
timeFrame: within 3 months after embolization
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Opthalmologique A de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
name: Raphaël BLANC, MD
role: PRINCIPAL_INVESTIGATOR
References: