Technical Development of Xe MRI in Children and Adults
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Xenon gas Defect Distribution Index (DDI)
研究概览
简要总结
The goal of this study is to develop and optimize new proton (1H; conventional MRI) and Xe gas MRI techniques to assess regional cardiopulmonary structure and function in the clinical setting. Specifically, three forms of Xe MRI techniques will be our focus: (1) imaging of the Xe ventilation distribution (which is the current FDA-approved indication for Xe MRI); (2) imaging the alveolar microstructure via the Xe apparent diffusion coefficient (ADC); and (3) detecting via spectroscopy and imaging Xe gas dissolved in the pulmonary blood and tissues upon inhalation.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is having a clinically-ordered hyperpolarized Xe gas MRI scan
排除标准
- •Pregnancy or positive pregnancy test
- •Standard MRI exclusions
研究组 & 干预措施
Hyperpolarized 129 Xenon
This research study will happen immediately following the clinical MRI exam with additional research Xe doses administered after the clinical Xe MRI procedure. Xe gas will be administered to the participant in the same manner as the clinical Xe MRI scan. Research scans without Xe gas may be acquired as well.
干预措施: Hyperpolarized 129 Xenon (Drug)
结局指标
主要结局
Xenon gas Defect Distribution Index (DDI)
时间窗: Through study completion, an average of 5 years
The signal intensity of Xe gas in a voxel (in arbitrary units) as compared to neighboring voxels, with a higher DDI indicating more clustered and focal Xe defects.
次要结局
- Apparent-Diffusion Coefficient (ADC) of Xe gas within the alveolar airspace.(Through study completion, an average of 5 years)
- Xenon RBC:Membrane ratio(Through study completion, an average of 5 years)
- Xe gas time constant(Through study completion, an average of 5 years)
- Length in time of Xe MRI acquisition(Through study completion, an average of 5 years)