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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT02629432
• Lead Sponsor: University Hospital Heidelberg

Brief Summary

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

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-14
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 602

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	single time point/baseline only	diagnostic study, MRI and CT acquired on the same day

Secondary Outcome Measures

Name	Time	Method
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	to assess the achievable image quality in a multicentre setting
number of cases in which MRI (i.e. functional parameters) produces clinically relevant additional information to CT	single time point/baseline only	to assess potential advantages of MR compared to CT
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	to compare both modalities for the assessment of those parameters
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	to assess the value of MRI-based biomarkers in comparison to clinical data

Trial Locations

Locations (15)

LungenClinic Grosshansdorf, Pneumologisches Forschungsinstitut; 🇩🇪 Grosshansdorf, Germany

Universitätsklinikum Gießen und Marburg GmbH,Klinik für Diagnostische und Interventionelle Radiologie; 🇩🇪 Giessen, Germany

Universitätsklinikum, Zentrum für Radiologie, Klinik für Diagnostische und Interventionelle Radiologie; 🇩🇪 Marburg, Germany

Hamburger Institut für Therapieforschung (HIT) GmbH; 🇩🇪 Hamburg, Germany

Thoraxklinik Heidelberg, Diagnostische und Interventionelle Radiologie; 🇩🇪 Heidelberg, Germany

Klinikum Nord-Nuernberg, Radiologie; 🇩🇪 Nuernberg, Germany

Universitätsklinikum des Saarlandes, Klinik für Diagnostische und Interventionelle Radiologie; 🇩🇪 Homburg, Germany

Universitätsklinikum, Diagnostische und Interventionelle Radiologie und Neuroradiologie; 🇩🇪 Essen, Germany

Universitätsklinikum Heidelberg, Diagnostische und Interventionelle Radiologie; 🇩🇪 Heidelberg, Germany

Universitätsmedizin Greifswald, Institut für Diagnostische Radiologie u. Neuroradiologie; 🇩🇪 Greifswald, Germany

Universitätsklinikum Schleswig Holstein, Klinik für Diagnostische Radiologie, Campus Kiel; 🇩🇪 Kiel, Germany

Institut für Klinische Radiologie, Klinikum der Universität Muenchen (KUM), Campus Innenstadt Muenchen; 🇩🇪 Muenchen, Germany

Medizinische Hochschule Hannover, Zentrum Radiologie, Institut für Diagnostische und Interventionelle Radiologie; 🇩🇪 Hannover, Germany

Universitätsklinikum Leipzig, Department für Bildgebung und Strahlenmedizin; 🇩🇪 Leipzig, Germany

Klinikum der Universität Muenchen, Institut für Klinische Radiologie; 🇩🇪 Muenchen, Germany