ISRCTN56900576已完成未知
Functional magnetic resonance lung imaging using inhaled hyperpolarised 129xenon in healthy volunteers and patients with chronic obstructive pulmonary disease
niversity of Nottingham0 个研究点目标入组 53 人开始时间: 2015年11月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 53
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 22/12/2022:
- •General inclusion criteria:
- •1. Aged 18 years or over
- •2. Capacity to give informed consent
- •3. Normal blood pressure (systolic BP > 100 mmHg and diastolic BP > 70 mmHg)
- •4. Resting heart rate > 50 bpm
- •5. For women, negative urinary ß-hCG at the screening and subsequent visits
- •6. Subject able to hold breath for 10 seconds
- •7. Subject able to fit into 129Xe chest coil used for MRI
- •8. Subject able to understand the requirements of the study and to cooperate with the study procedures
- •Healthy volunteer inclusion criteria:
- •No significant respiratory disease within the last year
- •COPD patient inclusion criteria:
- •1. Evidence of airflow obstruction (FEV/FVC <0.7) and FEV1 <80% predicted post bronchodilator
- •2. Minimum FVC 1.5L
- •Previous participant inclusion criteria:
- •General inclusion criteria:
- •1. Aged 18 years or over
- •2. Capacity to give informed consent
- •3. Normal blood pressure (systolic BP > 100 mmHg and diastolic BP > 70 mmHg)
- •4. Resting heart rate > 50 bpm
- •5. For women, negative urinary ß-hCG at the screening and subsequent visits
- •6. Subject able to hold breath for 10 seconds
- •7. Subject able to fit into 129Xe chest coil used for MRI
- •8. Subject able to understand the requirements of the study and to cooperate with the study procedures
- •Healthy volunteer inclusion criteria:
- •No significant respiratory disease within the last year
- •COPD patient inclusion criteria:
- •1. Evidence of airflow obstruction (FEV/FVC <0.7) and FEV1 <80% predicted post bronchodilator
- •2. Minimum FVC 1.5L
- •IPF patient inclusion criteria:
- •1. Diagnosis of IPF by high resolution CT scan
- •2. Full pulmonary function test performed within 12 months prior to imaging
- •3. Minimum FVC 1.5
排除标准
- •Healthy volunteer exclusion criteria:
- •1. Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
- •2. Acute respiratory illness within 30 days of MRI
- •3. Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
- •4. Subject deemed unlikely to comply with instructions during imaging
- •5. Do not meet the inclusion criteria above
- •6. Subject not deemed fit enough to tolerate procedure
- •7. Subject deemed unsuitable by clinical investigator for other reasons
- •COPD and IPD patient exclusion criteria:
- •1. Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
- •2. Acute respiratory illness within 30 days of MRI
- •3. Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
- •4. Subject deemed unlikely to comply with instructions during imaging
- •5. Do not meet the inclusion criteria above
- •6. Subject not deemed fit enough to tolerate procedure
- •7. Subject deemed unsuitable by clinical investigator for other reasons
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