Clinical trial NCT02629432: Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT
Official title: Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: MRI
COPD
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Philipps University Marburg
name: Hannover Medical School
First posted: 2015-12-14
Enrollment: 602
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This Trial is fully embedded within the main cohort of the Cosyconet-Study: Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis, Utilisation of Health care Ressources in Patients with COPD (COSYCONET), NCT01245933 ). Only patients included into the main study are asked to take part in this sub-trial which is not pharmaceutical and only has one arm including the expected number of patients (625) .

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: single time point/baseline only
Secondary outcomes:
measure: number of completed examinations with diagnostic image quality to determine the achievable diagnostic quality of lung MRI in a multi-center setting
timeFrame: single time point/baseline only
measure: agreement of visual and software-based phenotyping on MRI and CT (airway wall thickening, air trapping, emphysema, lung perfusion deficits)
timeFrame: single time point/baseline only
measure: 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)
timeFrame: single time point/baseline only
measure: number of cases in which MRI (i.e. functional parameters) produces clinically relevant additional information to CT
timeFrame: single time point/baseline only
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Universitätsklinikum, Diagnostische und Interventionelle Radiologie und Neuroradiologie
city: Giessen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH,Klinik für Diagnostische und Interventionelle Radiologie
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald, Institut für Diagnostische Radiologie u. Neuroradiologie
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf, Pneumologisches Forschungsinstitut
city: Hamburg
country: Germany
facility: Hamburger Institut für Therapieforschung (HIT) GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Zentrum Radiologie, Institut für Diagnostische und Interventionelle Radiologie
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg, Diagnostische und Interventionelle Radiologie
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg, Diagnostische und Interventionelle Radiologie
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes, Klinik für Diagnostische und Interventionelle Radiologie
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig Holstein, Klinik für Diagnostische Radiologie, Campus Kiel
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Department für Bildgebung und Strahlenmedizin
city: Marburg
country: Germany
facility: Universitätsklinikum, Zentrum für Radiologie, Klinik für Diagnostische und Interventionelle Radiologie
city: Muenchen
country: Germany
facility: Institut für Klinische Radiologie, Klinikum der Universität Muenchen (KUM), Campus Innenstadt Muenchen
city: Muenchen
country: Germany
facility: Klinikum der Universität Muenchen, Institut für Klinische Radiologie
city: Nuernberg
country: Germany
facility: Klinikum Nord-Nuernberg, Radiologie
Study officials:
affiliation: University Hospital Heidelberg
name: Juergen Biederer, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Heidelberg
name: Bertram Jobst, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Biederer J, Beer M, Hirsch W, Wild J, Fabel M, Puderbach M, Van Beek EJ. MRI of the lung (2/3). Why ... when ... how? Insights Imaging. 2012 Aug;3(4):355-71. doi: 10.1007/s13244-011-0146-8. Epub 2012 Feb 13.
citation: Wild JM, Marshall H, Bock M, Schad LR, Jakob PM, Puderbach M, Molinari F, Van Beek EJ, Biederer J. MRI of the lung (1/3): methods. Insights Imaging. 2012 Aug;3(4):345-53. doi: 10.1007/s13244-012-0176-x. Epub 2012 Jun 13.
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citation: Gietema HA, Muller NL, Fauerbach PV, Sharma S, Edwards LD, Camp PG, Coxson HO; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) investigators. Quantifying the extent of emphysema: factors associated with radiologists' estimations and quantitative indices of emphysema severity using the ECLIPSE cohort. Acad Radiol. 2011 Jun;18(6):661-71. doi: 10.1016/j.acra.2011.01.011. Epub 2011 Mar 9.