Functional and Structural Lung Imaging in Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To acquire structural and functional proton-based lung MRI scans from patients with COPD and COPD due to A1ATD and produce baseline data for these groups to inform future clinical studies
研究概览
简要总结
This study aims to use novel proton-based MRI techniques to assess lung function and structure in healthy volunteers and patients with chronic obstructive pulmonary disease (COPD) and alpha-1-anti-trypsin deficiency (A1ATD). These novel MRI measures will be compared to matched contemporary clinical diagnostic tools, namely pulmonary function tests (PFTs) and computed tomography (CT) scans. MRI has the advantages of avoiding ionising radiation exposure (unlike CT scans) and can also provide regional measures of lung function (unlike PFTs which provide global measures of function). In addition, these MRI techniques do not require the use of any inhaled or injected contrast agents.
Some patients enrolled in this study will be undergoing a lung volume reduction (LVR) procedure as part of their normal clinical care. LVR is an intervention for patients with severe lung disease and hyperinflation. It is a palliative therapy that helps to reduce lung hyperinflation through insertion of small valves in the airway or surgical removal of parts of the lung. This can lead to improvements in symptoms such as breathlessness and improve exercise tolerance due to better functioning of the lung. In this study, we will explore how lung MRI measures can be used to assess patients before and after an LVR intervention.
This study will take place at the University of Nottingham in collaboration with Nottingham University Hospitals NHS Trust. The study will last for 3 years and participants will be asked to attend a screening visit (lasting up to 1 hour) and either one or two study visits (each lasting up to 3 hours).
详细描述
This is a single centre pilot study. The research team aims to recruit adult healthy volunteers and adult patient volunteers with COPD and A1ATD. We have used similar proton-based MRI techniques in healthy volunteers and people with other lung diseases and the MRI scans have been well tolerated.
All participants will be adults (both male and female) who can give informed consent and are able to undertake the study procedures. Potential participants who cannot have an MRI scan for safety reasons (e.g. have a pacemaker) will not be recruited. During study visits, all research activities will be observed by a member of the research team.
During the screening visit (following consent), the following information and measures will be taken:
Relevant past medical history, COPD assessment tool (questionnaire), height, weight, blood pressure and pulse oximetry.
During study visits, a combination of structural and functional lung MRI scans will be performed with the participant lying in the scanner. Participants will be asked to breathe normally during scans and may also be asked to perform breathing manoeuvres such as holding their breath temporarily.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
To acquire structural and functional proton-based lung MRI scans from patients with COPD and COPD due to A1ATD and produce baseline data for these groups to inform future clinical studies
时间窗: 3 years
To compare functional MRI outcomes with matched clinical physiological data (e.g. pulmonary function tests) To compare structural lung images with matched conventional imaging techniques done for clinical reasons (e.g. computed tomography) of the diaphragm and lungs
次要结局
- To assess any change of MR outcomes across study visits for participants who undergo LVR(3 years)
- To assess the ability of participants of each group to adhere to the protocols, thus informing the study design of future trials(3 years)
- To assess any change of MR outcomes across study visits for those participants undertaking more than one MR scanning visit.(3 years)
研究者
Jonathan Brooke
Clinical Research Fellow
University of Nottingham