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临床试验/NCT01514617
NCT01514617进行中(未招募)不适用

Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Diffusion -and perfusion weighted MRI as a predictor for volumetric response of leiomyomas after uterine artery embolization

研究概览

简要总结

It is known that volumetric response of leiomyomas following uterine artery embolization correlates well with patients clinical outcome. The aim of this study is to assess diffusion -and perfusion weighted MRI for the prediction of volumetric response following uterine artery embolization in patients with symptomatic leiomyomas.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

性别
Female
接受健康志愿者
否

入选标准

  • •women with symptomatic leiomyomas

排除标准

  • •women with known contra-indications for MRI (cardiac pacemaker, cochlear implants, claustrophobic patients)
  • •women with contra-indications to gadolinium-based contrast agents (including patients with a known restricted renal function; GFR < 30 mL/min)

结局指标

主要结局

Diffusion -and perfusion weighted MRI as a predictor for volumetric response of leiomyomas after uterine artery embolization

时间窗: Participants will be followed for the duration of hospital stay (an expected average of 3 days) and will be systematically followed during their follow-up.

Patients will be scanned before (baseline) and after (the day of embolization, 3 days and 3 months after embolization). Measurements of signal intensity (SI) will be performed placing ROIs in the central portion of the lesion avoiding areas of artifact. Apparent diffusion coefficients (ADCs) will be calculated at different time points (before and after embolization). Signal intensity measurements on the dynamic contrast enhanced imaging data sets will be performed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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