NCT05744102尚未招募不适用
Evaluation of Advanced and New MRI Techniques to Improve Patient Diagnosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,016
- 试验地点
- 2
- 主要终点
- Image quality
研究概览
简要总结
The main objective of the research is to compare by two blind evaluators new MRI techniques with routinely used sequences.
详细描述
"The main evaluation criterion will be the choice of the two (or three) evaluators as to the best sequence between the new sequence and the standard sequence.
The decision criterion for considering a new sequence as superior to the standard sequence will be based on two measures:
- The proportion of patients for whom the new sequence was preferred, which must be greater than or equal to 75%;
- Inter-observer agreement (Cohen's Kappa coefficient), which must be greater than or equal to 0.8; When these two criteria are met, the new sequence will be considered superior to the standard 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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient
- •Patient who signed a consent to participate in the study
- •Affiliated patient or beneficiary of a social security scheme
- •Patient having an MRI scheduled as part of their care pathway
- •Absence of prohibition of participation in another research
排除标准
- •Patients under guardianship or curators
- •Pregnant or breastfeeding patients
- •Patients responding to a contraindication to performing an MRI
- •Patient under state medical aid (AME)
- •Adult patients protected by law
结局指标
主要结局
Image quality
时间窗: 7 years
The main evaluation criterion will be the choice of the two (or three) evaluators as to the best sequence between the new sequence and the standard sequence.
次要结局
- Acquisition period(7 years)
- Apnea(7 years)
研究者
研究点 (2)
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