MRI and CT phenotyping of 600 subjects from the German COPD trial COSYCONET: study concept and current status

Introduction: Imaging allows for precise characterization of regional lung alterations in COPD beyond global parameters such as spirometry. Since MRI allows for radiation-free regional morphological and functional assessment of the lung, it is the aim of this multi-centre study (ClinicalTrials.gov identifier NCT02629432) to evaluate sensitivity and specificity of morpho-functional MRI to diagnose emphysema-and airway-phenotypes of COPD, with CT as standard of reference.

Methods: Prospective lung imaging is being performed in a subcohort of 600 participants from COSYCONET, the national COPD Cohort. CT and MRI data are acquired at 16 study centres, which include all DZL-sites. Standardized protocols were defined for 1 H-MRI combining morphological and contrast-enhanced 3D dynamic perfusion acquisitions, and non-enhanced low-dose CT in inspiration and expiration (< 3.5 mSv). Phenotyping is performed by visual scoring and software-based analysis, providing quantitative CT-based airway- and emphysema parameters and quantitative MRI-based perfusion data.

Results: The study protocol, patient information and standardized SOPs for imaging were established. Quality control beyond regular scanner calibration is done by periodical phantom scans for CT and MRI. The workflow was implemented on occasion of initial training visits. The trial started in December 2013. Today, all centers were initiated and have already examined 592 participants. The recruiting period will end in June 2016.

Discussion: This study will define the role of MRI in phenotyping COPD and validate innovative biomarkers for interventional COPD trials. It also represents the close collaboration of radiology experts from the DZL-Platform Imaging and the representatives of the Disease Area COPD.