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临床试验/NCT03674645
NCT03674645招募中不适用

Test and Optimization of New Specific MRI Sequences on an Imager Dedicated to Research

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年9月19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
200
试验地点
1
主要终点
Image quality

研究概览

简要总结

Magnetic Resonance Imaging (MRI) performance depends on equipment performance, equipment maintenance and relevance of MRI sequence used. To optimize MRI performance, it's necessary to develop, optimize, test and validate new acquisition sequences for enhanced diagnosis and therapy monitoring. These new sequences will allow better spatial resolution and specificity while reducing acquisition time.

详细描述

The purpose of the present study is to test and optimize, on healthy subjects, specific MRI acquisition sequences firstly developed in a preclinical phase on phantoms (inert objects containing solutions or gels) and animal (Pig, sheep). This study will allow the investigators to define practical acquisition parameters that will allow reproducible results and precise definition of clinically relevant examination protocols for each new developed sequence.

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

入选标准

  • Healthy volunteers (over 18 yo),
  • Male or female,
  • Affiliated to social security,
  • Without any contraindication to MRI exam and who will have signed a written inform consent.

排除标准

  • Individuals deprived of liberty,
  • Under guardianship or curatorship,
  • Persons with known disease which could disturb MRI acquisition or with absolute or relative contraindication to an MRI examination
  • Pregnant women,
  • Breastfeeding women,
  • Women without effective contraception,
  • Participants who refused to be informed of the possible discovery of a significant anomaly,
  • Persons involved in an interventional study with a drug or an implantable device.

研究组 & 干预措施

MRI

Experimental

MRI exam performed on 200 healthy volunteers

干预措施: MRI acquisitions (Device)

结局指标

主要结局

Image quality

时间窗: Day 0

Qualitative interpretation of image quality to respiratory and cardiac motions

时间窗: Day 0

In the presence of improper compensation for cardiac and / or respiratory movements, the images may appear blurred. The qualitative interpretation of image quality will be performed by visual image analysis.

Signal to noise ratio

时间窗: Day 0

Total acquisition time

时间窗: Day 0

Contrasts between structurally different regions

时间窗: Day 0

The values of the signal intensities will be measured in adjacent structures of interest. The difference between these values divided by the noise will be calculated to quantify the contrast-to-noise ratio between these structures. The higher this value is, the better is the sequence in its ability to differentiate these structures from one another.

Quantitative interpretation of image quality to respiratory and cardiac motions

时间窗: Day 0

In the presence of improper compensation for cardiac and / or respiratory movements, the images may appear blurred. The quantitative interpretation of image quality will be performed by a measurement of sharpness of contours between adjacent structures of interest.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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