NCT02529475终止4 期
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)
University Hospital, Grenoble3 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2016年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging
研究概览
简要总结
- This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in healthy subjects
- MR Perfusion Imaging will be assess in both cochlea as well
- Primary auditory brain pathways will be evaluated through MR diffusion imaging
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Major subjects of over 40 years (mean age of Meniere's disease 40 to 50 years)
- •Informed consent signed
- •Medical examination performed prior to participation in research
- •Patients without history of inner ear disease
- •Recipient of a French social security scheme
排除标准
- •Patients minors
- •Patients on a legal protection regime type guardianship
- •Respiratory pathologies, cardiovascular, renal, diabetes
- •Claustrophobia
- •Contraindications to exposure to a magnetic field
- •Contraindications to injecting Dotarem ®
研究组 & 干预措施
Gadoteric acid
Experimental
Gadoteric acid 0.2 mmol/kg
干预措施: Gadoteric acid (Drug)
结局指标
主要结局
Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging
时间窗: One MR scan (4 hours)
次要结局
未报告次要终点
研究者
研究点 (3)
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