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临床试验/NCT02896881
NCT02896881终止不适用

Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations (MAV-IRM)

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
53
试验地点
1
主要终点
sensitivity of multisequence MRI to detect a residual arteriovenous malformation after embolization

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient ≥ 18 years old
  • with brain Arteriovenous Malformations
  • embolization treatment scheduled

排除标准

  • patient's refusal to participate in the study
  • contraindication to undergo MRI examination
  • patient under legal protection

结局指标

主要结局

sensitivity of multisequence MRI to detect a residual arteriovenous malformation after embolization

时间窗: within 3 months after embolization

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).

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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