Assessment of New Magnetic Resonance Imaging (MRI) Pulse Sequences for Imaging Hyperpolarised Xenon in Lung, Heart and Brain in Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Qualitative assessment of images 3
研究概览
简要总结
Hyperpolarised gas Magnetic resonance imaging (MRI) (Hyperpolorised 3He and 129Xe MRI) provides novel regional functional images of the lungs. Over the past 14 years researchers at Sheffield Teaching Hospitals NHS Foundation Trust and University of Sheffield have been developing and evaluating different MRI techniques to investigate different aspects of the lung function with both Hyperpolorised 3He and more recently 129Xe gas and have tested these new methods in volunteers with healthy and diseased lungs. This proposed study is to further test the sensitivity of MRI pulse sequences with inhaled 129Xe gas in volunteers. This protocol serves to evaluate the sensitivity of pulse sequences for 129Xe magnetic resonance imaging in the lungs and monitoring the transient changes in vital signs during and following the gas inhalation. This includes evaluation of pulse sequences to image xenon in the heart and brain as well as in the lungs of volunteers.
详细描述
The primary endpoints are to test the pulse sequences under development to image lung ventilation and perfusion, cardiac perfusion and brain uptake of xenon
The study will seek to test the given pulse sequence under investigation in a group of up to 40 volunteers.
To be eligible, each subject will have no contraindications to MRI scanning and will have signed the necessary volunteer consent forms.
The target recruitment number should provide sufficient data to determine the efficacy of the techniques under development.
Methods HP 129Xe MRI scans will be performed. MRI images will be acquired with the patients supine inside a 129Xe-capable MRI system, (1.5 Tesla GE, USA or 3.0 Tesla Philips, Netherlands), using dedicated transmit-receive radio-frequency coils.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age greater than 18, less than
- •NB: Participants will also be permitted to take part in study STH15080 (Eudract number 2009-010815-34, 'Development of new Magnetic resonance imaging (MRI) pulse sequences for probing lung function in volunteers with hyperpolarised 3He gas').
排除标准
- •Contraindication to MRI.
- •Resting oxygen saturation less than 90%.
- •Known disease of the lungs, heart or brain.
- •Pregnant.
- •Volunteer eligibility will be determined by completion of the study screening form not by physical examination or testing. Eligibility will be confirmed by a clinician upon review of the study screening form, prior to completing the study prescription for xenon dosing.
结局指标
主要结局
Qualitative assessment of images 3
时间窗: Baseline
presence of artifacts
Qualitative assessment of images 2
时间窗: Baseline
spatial resolution
Qualitative assessment of images 1
时间窗: Baseline
signal to noise ratio,
次要结局
未报告次要终点