NCT06373796已完成不适用
Comparison of the Ultrasound Index Fat Fraction (FAT PLUS) With the MRI-PDFF Score for Quantification of Hepatic Steatosis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- FAT PLUS
研究概览
简要总结
The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is ≥ 18 years old.
- •Subject is able to understand and sign the Informed Consent Form.
- •Subject is able to stand and walk independently.
- •Subject must have at least one or more routine ultrasound imaging procedures of the abdomen, at one of the participating study sites.
- •Subject must have at least one routine liver MRI with PDFF score performed within 30 days before or after the ultrasound examination
- •Subject is affiliated to National Social Insurance or a Health Insurance Regimen
排除标准
- •Subject is unable or unwilling to adhere to Study procedures
- •Subject is unable to understand the Informed Consent
- •Subject is unable to express its consent
- •Subject is under legal protection
- •Subject is deprived of liberty by judicial or administrative decision
- •Subject undergoes psychiatric treatment under constraint
- •Subject is pregnant or breastfeeding
- •Subject has latex allergy
- •Subject has an open wound, cut, and/or a rash which would preclude an ultrasound imaging procedure
结局指标
主要结局
FAT PLUS
时间窗: 3 months
The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis.
次要结局
未报告次要终点
研究者
研究点 (2)
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