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

NCT02629432 | Completed DMC

• 1 other identifier: 01GI0884
• Study Type: observational
• Target: 602
• Locations: 1 country
• Sites: 15

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

MRI; COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• 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

• number of cases in which MRI (i.e. functional parameters) produces clinically relevant additional information to CT

  single time point/baseline only

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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) .

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Philipps University Marburg: collaborator
• Hannover Medical School: collaborator

Study Sites (15)

Universitätsklinikum, Diagnostische und Interventionelle Radiologie und Neuroradiologie

Essen, 45147, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH,Klinik für Diagnostische und Interventionelle Radiologie

Giessen, 35392, Germany

Location

Universitätsmedizin Greifswald, Institut für Diagnostische Radiologie u. Neuroradiologie

Greifswald, 17475, Germany

Location

LungenClinic Grosshansdorf, Pneumologisches Forschungsinstitut

Großhansdorf, 22927, Germany

Location

Hamburger Institut für Therapieforschung (HIT) GmbH

Hamburg, 20354, Germany

Location

Medizinische Hochschule Hannover, Zentrum Radiologie, Institut für Diagnostische und Interventionelle Radiologie

Hanover, 30625, Germany

Location

Universitätsklinikum Heidelberg, Diagnostische und Interventionelle Radiologie

Heidelberg, 69120, Germany

Location

Thoraxklinik Heidelberg, Diagnostische und Interventionelle Radiologie

Heidelberg, 69126, Germany

Location

Universitätsklinikum des Saarlandes, Klinik für Diagnostische und Interventionelle Radiologie

Homburg, 66421, Germany

Location

Universitätsklinikum Schleswig Holstein, Klinik für Diagnostische Radiologie, Campus Kiel

Kiel, 24105, Germany

Location

Universitätsklinikum Leipzig, Department für Bildgebung und Strahlenmedizin

Leipzig, 04103, Germany

Location

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

Marburg, 35043, Germany

Location

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

München, 80336, Germany

Location

Klinikum der Universität Muenchen, Institut für Klinische Radiologie

München, 81377, Germany

Location

Klinikum Nord-Nuernberg, Radiologie

Nuremberg, 90419, Germany

Location

Related Publications (6)

• 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.

  PMID: 22695943 BACKGROUND

• 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.

  PMID: 22695944 BACKGROUND

• 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.

  PMID: 22695952 BACKGROUND

• 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.

  PMID: 21429685 BACKGROUND

• 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.

  PMID: 22429093 BACKGROUND

• 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.

  PMID: 21393027 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juergen Biederer, Professor

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

• Bertram Jobst, Dr.

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: December 14, 2015
• Study Start: December 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (15)