Use of Hyperpolarized 129 Xe MR Lung Imaging in Children and Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI
研究概览
简要总结
The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas MRI for regional assessment of lung function in a normal population of children and adults and in adults and also in children with respiratory compromise due to a variety of diseases.
详细描述
Hyperpolarized 129Xe will be produced, by trained staff, using a polarizer housed at Cincinnati Children's Hospital Medical Center. Individual imaging sessions will be done on a single day and will involve administration of (maximum) 1 liter doses (less for children) for up to four MRI scans. Subject will inhale hyperpolarized xenon gas and hold breath for up to 16 seconds during the MRI scans. In addition to 129 Xe MRI, a series of anatomical conventional proton MR images may also be collected. Follow up phone calls will be done one day and 30 days from the MRI date.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 6 and up
- •Participant must be able to hold breath for up to 16 seconds
排除标准
- •History of heart defect
- •Pregnancy or positive pregnancy test
- •History of uncontrolled asthma defined for this study as requiring use of rescue inhaler ≥ 2 times in past month
- •Symptoms of respiratory infection (loose or productive cough or wheeze), chest tightness, or sinus infection within past week
- •Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula
- •Participant is claustrophobic and unable to tolerate the imaging.
- •Standard MRI exclusions (metal, implants)
研究组 & 干预措施
Hyperpolarized 129 Xenon
Administration of up to 1 liter doses of Hyperpolarized Xenon gas during MRI (less for children) to optimize acquisition of images for children and adults vs. proton MR imaging
干预措施: Hyperpolarized 129 Xenon (Drug)
结局指标
主要结局
Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI
时间窗: Day 1
quantify the measurement agreement between the ventilated volume of healthy lungs predicted via 129 Xe MRI and the ventilated volume of the pleural cavity predicted via proton MRI
次要结局
未报告次要终点