Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR COPD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 602
- 试验地点
- 15
- 主要终点
- Sensitivity and specificity of MRI for the diagnosis of emphysema-predominant vs. airway-predominant COPD phenotype based on semi-quantitative visual image evaluation with CT as standard of reference
研究概览
简要总结
The main objective of this trial is to prove that MRI - as the imaging modality without the use of ionizing radiation - can replace CT for structural and functional regional phenotyping of COPD. The identification of different COPD phenotypes, such as the "emphysema-type" and the "airway-type", is important because therapy and prognosis will be different. The medical problem addressed in this trial is the image-based phenotyping of COPD. The sensitivity and specificity of MRI will be compared to Lowdose-CT serving as the gold standard. MRI and CT of the lung will be performed in a multi-centre cohort of 625 COPD-patients from the main COSYCONET cohort. The reliability of the MRI results will be demonstrated. MRI phenotypes will be evaluated visually and using software with quantitative read-outs. The agreement of both will be determined. The additional information of MRI over CT will be assessed.
详细描述
This prospective trial aims to phenotype COPD by using Imaging methods.The identification of different COPD phenotypes, such as the "emphysema-type" and the "airway-type", is important because therapy and prognosis will be different. Imaging might play a central role in diagnosing these phenotypes. So far computed tomography (CT) is regarded as the gold standard, but it involves ionizing radiation and lacks functional information. The medical problem addressed in this trial is the image-based phenotyping of COPD. The principal research question is whether magnetic resonance imaging (MRI) can replace CT for the characterization of COPD by "structural and functional phenotyping" on a regional basis. The sensitivity and specificity of MRI will be compared to CT serving as the gold standard. To achieve this goal, MRI and CT of the lung will be performed in a multi-centre cohort of 625 COPD-patients from the main Cosyconet cohort. Also, the reliability of the MRI results will be demonstrated. MRI phenotypes will be evaluated visually and using software with quantitative read-outs. The agreement of both will be determined. The additional information of MRI over CT will be assessed. A special focus will be to implement an image-based biomarker of pulmonary functional reserve derived from the MRI measurement of pulmonary perfusion, which will be correlated with results from pulmonary functions tests (e.g. the lung transfer factor for carbon monoxide (TLCO)) the 6-minute walking test (6-MWD), and extrapulmonary disease manifestations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The population to be studied is determined by the main Cosyconet-cohort.
- •Key inclusion criteria:
- •being included into the main cohort
- •diagnosis of COPD (GOLD criteria)
- •availability for repeated study visits
- •male or female
- •age > 40 years
排除标准
- •Key exclusion criteria as determined by the main Cosyconet-cohort:
- •having undergone lung surgery (e.g., lung volume reduction, lung transplant)
- •moderate or severe exacerbation within the last 4 weeks prior to visit 1
- •unable to understand the intention of the project
- •lack of signed patient informed consent
- •contraindications for MRI
- •pregnancy
结局指标
主要结局
Sensitivity and specificity of MRI for the diagnosis of emphysema-predominant vs. airway-predominant COPD phenotype based on semi-quantitative visual image evaluation with CT as standard of reference
时间窗: single time point/baseline only
diagnostic study, MRI and CT acquired on the same day
次要结局
- number of completed examinations with diagnostic image quality to determine the achievable diagnostic quality of lung MRI in a multi-center setting(single time point/baseline only)
- number of cases in which MRI (i.e. functional parameters) produces clinically relevant additional information to CT(single time point/baseline only)
- agreement of visual and software-based phenotyping on MRI and CT (airway wall thickening, air trapping, emphysema, lung perfusion deficits)(single time point/baseline only)
- correlation of MRI metrics with clinical tests: predictive value of perfusion MRI for pulmonary functional reserve compared to clinical tests, i.e. pulmonary function tests (TLCO) and six-minute walk test (6 MWT)(single time point/baseline only)
研究者
Prof. Dr. Juergen Biederer
Prof. Dr.
University Hospital Heidelberg