Arterial Spin Labeling MRI for Assessing Blood Perfusion in the Human Eye Repeatability Study and Clinical Application
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Repeatability measurement on volunteers
研究概览
简要总结
The MRI perfusion imaging using arterial spin labeling (ASL)'s non-invasive technique (i.e. without injection of contrast medium) allows, thanks to recent technological improvement of the spatial resolution, measuring several perfusion parameter of the retinal tissue such as the regional Blood Flow (rBF) or the cerebral blood flow (cBF) expressed in ml/100g/min. Reliable application of ASL thus requires the precision and specificity of the MRI protocol to be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Carrier of target pathologies: TAO optic neuropathy, inflammatory optic neuropathy, ischemic optic neuropathy.
- •no cardiovascular risk factors or other ophthalmological pathology
- •adhere to the study protocol after reading the patient information document
- •signe the informed consent form to participate in the study
- •do not have any contraindications to an MRI examination
排除标准
- •Usual contraindications to MRI (Pacemaker, Metallic foreign body, Cochlear implant,…)
- •Severe claustrophobia
结局指标
主要结局
Repeatability measurement on volunteers
时间窗: 2 month
implementing a protocol based on 2 imaging sessions : 1st session with 2 ASL sequences and a 2nd session scheduled 5-7 days later in similar conditions including 1 ASL in volunteers will be applied. This protocol allows assessing the intra-day and the inter-day variability of the measurements using Intra-Class Correlation Coefficient and metric derived from Bland-Altman plots. A total of 20 MRI examinations are planned for this phase of the study.
次要结局
- Mesurement of the retinal perfusion by MRI ASL in patient in acute phase(4 years)
- Mesurement of the retinal perfusion by MRI ASLin patient in a chronic phase(4 years)