A Pilot Study for Evaluation of Regional Lung Function in Normal Subjects and Subjects With Airway and Lung Disorders Using 1H Magnetic Resonance Imaging With Oxygen as a Contrast Agent
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Image Quality
研究概览
简要总结
The goal of this study is to perform a pilot study to evaluate the utilization of oxygen as an inhaled contrast agent to image the airway spaces in normal and diseased human lungs to allow an effect size estimate to power future studies.
详细描述
This is an open label study expanding on work by other groups in animals, ex-vivo human lungs and human subjects. Both 2-dimensional and 3-dimensional images will be obtained using 1H MRI comparing images obtained while breathing oxygen to those obtained breathing room air.
Objectives
- To determine if 1H magnetic resonance images of the human lung and airways can be obtained in both single breath-hold and gated breathing imaging studies with adequate signal level and image contrast to extract regional lung functional information with oxygen as a contrast agent.
- To determine the short term reproducibility of the lung functional imaging in a subset of subjects (5 control subjects and 5 subjects with lung disease) with repeat MRI studies (Visit 2) at a time point ≥ 1 week to ≤ 4 weeks from Visit 1
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Normal Subject
Each subject will receive oxygen as a contrast agent to visualize the airway and alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures. The subjects will receive the gas by breathing room air interleaved with oxygen using a standard Douglas Bag system. No additional drug products, investigational or otherwise will be provided in this study.
干预措施: Medical Grade Oxygen (Drug)
Subjects with Lung/or Airway Disease
Each subject will receive oxygen as a contrast agent to visualize the airway and alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures. The subjects will receive the gas by breathing room air interleaved with oxygen using a standard Douglas Bag system. No additional drug products, investigational or otherwise will be provided in this study.
干预措施: Medical Grade Oxygen (Drug)
结局指标
主要结局
Image Quality
时间窗: one exposure
Assessment of image quality of oxygen enhanced MR images: Signal to Noise Ratio, Dynamic Range of Ratio/Difference Images
次要结局
未报告次要终点
研究者
Hal C Charles
Associate Professor Department of Radiology
Duke University