EUCTR2011-002038-37-GB进行中（未招募）1 期
Hyperpolarised xenon magnetic resonance imaging (Xe-129 MRI) lung imaging in COPD - Xenon lung imaging in COPD: a COPD Cohort sub-study Version 1.0
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients with a diagnosis of COPD, with at least mild disease (stage II – IV on GOLD criteria classification, FEV1 <80% predicted and FEV1/ FVC <70%25)
- •Significant smoking history (>15 pack years, where a pack year is the product of [average number of cigarettes smoked per day] and [number of years smoked for] divided by 20) or other definite cause of COPD
- •Patients over the age of 18 who are willing and able to give informed consent to participate in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Co-existent cardio-pulmonary disease that predominates over COPD and might confound results interpretation (for example asthma, bronchiectasis, cystic fibrosis, lung cancer, uncontrolled heart failure, frequent unstable angina, respiratory muscle weakness)
- •Other major co-morbidity such that life expectancy is less than 24 months due to a cause other than COPD
- •Exclusion criteria for CT scanning
- •Inability to lie flat
- •Exclusion criteria for MR imaging
- •Inability to lie flat
- •Severe claustrophobia
- •Presence of a cardiac pace-maker or non-MRI compatible metallic implant
- •Intra-ocular foreign body
- •Epilepsy requiring on-going medical treatment, or a seizure within the past year
- •Exclusion criteria for gadolinium enhanced lung MRI scanning
- •Known hypersensitivity/ allergy to the injection of MultiHance that is given as part of this scanning or an adverse reaction to an injection given during previous MRI scanning. MultiHance contains gadobenate dimeglumine and small quantities of benzyl alcohol.
- •Severe renal impairment
- •Exclusion criteria for ventilation/perfusion nuclear medicine scanning
- •Known hypersensitivity to albumin or preference to avoid blood donation product
- •Exclusion criteria for salbutamol intervention component of study
- •Known hypersensitivity to salbutamol or to any of the excipients
- •Inability to omit long acting bronchodilators for 24 hours prior to the start of the study, and short acting bronchodilators on the day of the study until measurements are complete.
研究者
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