NCT05218460招募中不适用
Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects
Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2022年5月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 720
- 试验地点
- 2
- 主要终点
- Image quality based on standard imaging quality criteria
研究概览
简要总结
The EDEN study will make it possible to evaluate one or more development phases (from design to validation through optimization) of a method or a technique on voluntary subjects, in normal or pathological condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for all subjects :
- •to be over 18 year-old,
- •to be enrolled in a social security plan,
- •to have underwent a pre-inclusion medical examination,
- •to give a written consent.
- •Inclusion Criteria for volunteers with pathology :
- •- person with a pathology characterized by a functional and / or morphological alteration that may have an impact on the data collected (images, physiological signals, ...).
排除标准
- •for all subjects :
- •any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, … ),
- •subject under a measure of legal protection,
- •Person who refuses to be informed by a doctor in th event of a fortuitus discovery of an abnormality on the MRI examination requiring additionnal examinations or specific treatment.
研究组 & 干预措施
All subjects will have an MRI examination
Experimental
干预措施: MRI examination (Device)
结局指标
主要结局
Image quality based on standard imaging quality criteria
时间窗: 6 months after the last inclusion
The image quality will be appreciated visually at least by a radiologist or a researcher.
Signal quality based on standard signal quality criteria
时间窗: 6 months after the last inclusion
The signal quality will be appreciated visually at least by a radiologist or a researcher.
次要结局
- Comparison of the Contrast to Noise Ratio obtained by the component of the MRI system under development and the reference situation.(6 months after the last inclusion)
- Comparison of blurring and artefacts obtained by the component of the MRI system under development and the reference situation.(6 months after the last inclusion)
- Comparison of the Signal to Noise Ratio obtained by the component of the MRI system under development and the reference situation.(6 months after the last inclusion)
研究者
Pedro TEIXEIRA-GONDIM, MD
Principal Investigator
Central Hospital, Nancy, France
研究点 (2)
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