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

NCT ID: NCT02629432

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 602 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-07-31

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cosyconet COPD Cohort

MRI and CT of the lung will be performed in a multi-centre cohort of 625 COPD-patients from the main COSYCONET cohort.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• The population to be studied is determined by the main Cosyconet-cohort.

• being included into the main cohort
• diagnosis of COPD (GOLD criteria)
• availability for repeated study visits
• male or female
• age > 40 years

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philipps University Marburg

OTHER

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Juergen Biederer

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juergen Biederer, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Bertram Jobst, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

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

Universitätsklinikum Leipzig, Department für Bildgebung und Strahlenmedizin

Leipzig, , Germany

Universitätsklinikum, Zentrum für Radiologie, Klinik für Diagnostische und Interventionelle Radiologie

Marburg, , Germany

Institut für Klinische Radiologie, Klinikum der Universität Muenchen (KUM), Campus Innenstadt Muenchen

München, , Germany

Klinikum der Universität Muenchen, Institut für Klinische Radiologie

München, , Germany

Klinikum Nord-Nuernberg, Radiologie

Nuremberg, , Germany

Countries

Germany

References

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Reference Type: BACKGROUND

PMID: 22695943 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 22695944 (View on PubMed)

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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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Other Identifiers

01GI0884

Identifier Type: -

Identifier Source: org_study_id