Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR COPD)

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cosyconet COPD Cohort<br>MRI and CT of the lung will be performed in a multi-centre cohort of 625 COPD-patients from the main COSYCONET cohort. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | diagnostic study, MRI and CT acquired on the same day | single time point/baseline only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of completed examinations with diagnostic image quality to determine the achievable diagnostic quality of lung MRI in a multi-center setting | to assess the achievable image quality in a multicentre setting | 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) | to compare both modalities for the assessment of those parameters | 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) | to assess the value of MRI-based biomarkers in comparison to clinical data | single time point/baseline only | 
| number of cases in which MRI (i.e. functional parameters) produces clinically relevant additional information to CT | to assess potential advantages of MR compared to CT | single time point/baseline only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, COPD