- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02629432
Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR-COPD)
May 10, 2017 updated by: Prof. Dr. Juergen Biederer, University Hospital Heidelberg
Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR COPD)
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
602
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Essen, Germany, 45147
- Universitätsklinikum, Diagnostische und Interventionelle Radiologie und Neuroradiologie
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Giessen, Germany, 35392
- Universitätsklinikum Gießen und Marburg GmbH,Klinik für Diagnostische und Interventionelle Radiologie
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Greifswald, Germany, 17475
- Universitätsmedizin Greifswald, Institut für Diagnostische Radiologie u. Neuroradiologie
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Grosshansdorf, Germany, 22927
- LungenClinic Grosshansdorf, Pneumologisches Forschungsinstitut
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Hamburg, Germany, 20354
- Hamburger Institut für Therapieforschung (HIT) GmbH
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Hannover, Germany, 30625
- Medizinische Hochschule Hannover, Zentrum Radiologie, Institut für Diagnostische und Interventionelle Radiologie
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Heidelberg, Germany, 69126
- Thoraxklinik Heidelberg, Diagnostische und Interventionelle Radiologie
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Heidelberg, Germany, 69120
- Universitätsklinikum Heidelberg, Diagnostische und Interventionelle Radiologie
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Homburg, Germany, 66421
- Universitätsklinikum des Saarlandes, Klinik für Diagnostische und Interventionelle Radiologie
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Kiel, Germany, 24105
- Universitätsklinikum Schleswig Holstein, Klinik für Diagnostische Radiologie, Campus Kiel
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Leipzig, Germany, 04103
- Universitätsklinikum Leipzig, Department für Bildgebung und Strahlenmedizin
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Marburg, Germany, 35043
- Universitätsklinikum, Zentrum für Radiologie, Klinik für Diagnostische und Interventionelle Radiologie
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Muenchen, Germany, 80336
- Institut für Klinische Radiologie, Klinikum der Universität Muenchen (KUM), Campus Innenstadt Muenchen
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Muenchen, Germany, 81377
- Klinikum der Universität Muenchen, Institut für Klinische Radiologie
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Nuernberg, Germany, 90419
- Klinikum Nord-Nuernberg, Radiologie
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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) .
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: single time point/baseline only
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diagnostic study, MRI and CT acquired on the same day
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single time point/baseline only
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of completed examinations with diagnostic image quality to determine the achievable diagnostic quality of lung MRI in a multi-center setting
Time Frame: single time point/baseline only
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to assess the achievable image quality in a multicentre setting
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single time point/baseline only
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agreement of visual and software-based phenotyping on MRI and CT (airway wall thickening, air trapping, emphysema, lung perfusion deficits)
Time Frame: single time point/baseline only
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to compare both modalities for the assessment of those parameters
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single time point/baseline only
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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)
Time Frame: single time point/baseline only
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to assess the value of MRI-based biomarkers in comparison to clinical data
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single time point/baseline only
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number of cases in which MRI (i.e. functional parameters) produces clinically relevant additional information to CT
Time Frame: single time point/baseline only
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to assess potential advantages of MR compared to CT
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single time point/baseline only
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Juergen Biederer, Professor, University Hospital Heidelberg
- Principal Investigator: Bertram Jobst, Dr., University Hospital Heidelberg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Biederer J, Mirsadraee S, Beer M, Molinari F, Hintze C, Bauman G, Both M, Van Beek EJ, Wild J, Puderbach M. MRI of the lung (3/3)-current applications and future perspectives. Insights Imaging. 2012 Aug;3(4):373-86. doi: 10.1007/s13244-011-0142-z. Epub 2012 Jan 15.
- 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.
- 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.
- Eichinger M, Optazaite DE, Kopp-Schneider A, Hintze C, Biederer J, Niemann A, Mall MA, Wielputz MO, Kauczor HU, Puderbach M. Morphologic and functional scoring of cystic fibrosis lung disease using MRI. Eur J Radiol. 2012 Jun;81(6):1321-9. doi: 10.1016/j.ejrad.2011.02.045. Epub 2011 Mar 23.
- COPDGene CT Workshop Group; Barr RG, Berkowitz EA, Bigazzi F, Bode F, Bon J, Bowler RP, Chiles C, Crapo JD, Criner GJ, Curtis JL, Dass C, Dirksen A, Dransfield MT, Edula G, Erikkson L, Friedlander A, Galperin-Aizenberg M, Gefter WB, Gierada DS, Grenier PA, Goldin J, Han MK, Hanania NA, Hansel NN, Jacobson FL, Kauczor HU, Kinnula VL, Lipson DA, Lynch DA, MacNee W, Make BJ, Mamary AJ, Mann H, Marchetti N, Mascalchi M, McLennan G, Murphy JR, Naidich D, Nath H, Newell JD Jr, Pistolesi M, Regan EA, Reilly JJ, Sandhaus R, Schroeder JD, Sciurba F, Shaker S, Sharafkhaneh A, Silverman EK, Steiner RM, Strange C, Sverzellati N, Tashjian JH, van Beek EJ, Washington L, Washko GR, Westney G, Wood SA, Woodruff PG. A combined pulmonary-radiology workshop for visual evaluation of COPD: study design, chest CT findings and concordance with quantitative evaluation. COPD. 2012 Apr;9(2):151-9. doi: 10.3109/15412555.2012.654923. Epub 2012 Mar 19.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
October 23, 2015
First Submitted That Met QC Criteria
December 9, 2015
First Posted (Estimate)
December 14, 2015
Study Record Updates
Last Update Posted (Actual)
May 11, 2017
Last Update Submitted That Met QC Criteria
May 10, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01GI0884
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Pseudonymized Data from structured image reads will be transferred to the central COSYCONET data bank in Hannover.
Application form for project proposals and data retrieval can be downloaded here: http://www.asconet.net/html/cosyconet/projects?clps4835_49326291=1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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