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.
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.
Study Type
OBSERVATIONAL
Enrollment
602
Universitätsklinikum, Diagnostische und Interventionelle Radiologie und Neuroradiologie
Essen, Germany
Universitätsklinikum Gießen und Marburg GmbH,Klinik für Diagnostische und Interventionelle Radiologie
Giessen, Germany
Universitätsmedizin Greifswald, Institut für Diagnostische Radiologie u. Neuroradiologie
Greifswald, Germany
LungenClinic Grosshansdorf, Pneumologisches Forschungsinstitut
Großhansdorf, Germany
Hamburger Institut für Therapieforschung (HIT) GmbH
Hamburg, Germany
Medizinische Hochschule Hannover, Zentrum Radiologie, Institut für Diagnostische und Interventionelle Radiologie
Hanover, Germany
Universitätsklinikum Heidelberg, Diagnostische und Interventionelle Radiologie
Heidelberg, Germany
Thoraxklinik Heidelberg, Diagnostische und Interventionelle Radiologie
Heidelberg, Germany
Universitätsklinikum des Saarlandes, Klinik für Diagnostische und Interventionelle Radiologie
Homburg, Germany
Universitätsklinikum Schleswig Holstein, Klinik für Diagnostische Radiologie, Campus Kiel
Kiel, Germany
...and 5 more locations
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
Time frame: single time point/baseline only
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: single time point/baseline only
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.