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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— MR-COPD  

Official title:

Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629432
• Other study ID #: 01GI0884
• Status: Completed
• Phase: N/A
• First received: October 23, 2015
• Last updated: May 10, 2017
• Start date: December 2013
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Germany	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	Hannover
Germany	Thoraxklinik Heidelberg, Diagnostische und Interventionelle Radiologie	Heidelberg
Germany	Universitätsklinikum 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	Muenchen
Germany	Klinikum der Universität Muenchen, Institut für Klinische Radiologie	Muenchen
Germany	Klinikum Nord-Nuernberg, Radiologie	Nuernberg

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Hannover Medical School, Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

Eichinger M, Optazaite DE, Kopp-Schneider A, Hintze C, Biederer J, Niemann A, Mall MA, Wielpütz 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. — View Citation

Gietema HA, Müller 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	diagnostic study, MRI and CT acquired on the same day	single time point/baseline only
Secondary	number of completed examinations with diagnostic image quality to determine the achievable diagnostic quality of lung MRI in a multi-center setting	to assess the achievable image quality in a multicentre setting	single time point/baseline only
Secondary	agreement of visual and software-based phenotyping on MRI and CT (airway wall thickening, air trapping, emphysema, lung perfusion deficits)	to compare both modalities for the assessment of those parameters	single time point/baseline only
Secondary	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)	to assess the value of MRI-based biomarkers in comparison to clinical data	single time point/baseline only
Secondary	number of cases in which MRI (i.e. functional parameters) produces clinically relevant additional information to CT	to assess potential advantages of MR compared to CT	single time point/baseline only