AzTrials
AzTrials

Chronic Obstructive Pulmonary Disease (COPD)MR-COPDNCT02629432

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

An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by University Hospital Heidelberg at 15 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 40 years and older
How many people
602 participants
Where
15 sitesGermany
Study dates
Dec 2013to Jul 2016
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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) .

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Germany15 sites

  • Universitätsklinikum, Diagnostische und Interventionelle Radiologie und Neuroradiologie

    Essen, 45147

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

    Giessen, 35392

  • Universitätsmedizin Greifswald, Institut für Diagnostische Radiologie u. Neuroradiologie

    Greifswald, 17475

  • LungenClinic Grosshansdorf, Pneumologisches Forschungsinstitut

    Großhansdorf, 22927

  • Hamburger Institut für Therapieforschung (HIT) GmbH

    Hamburg, 20354

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

    Hanover, 30625

  • Universitätsklinikum Heidelberg, Diagnostische und Interventionelle Radiologie

    Heidelberg, 69120

  • Thoraxklinik Heidelberg, Diagnostische und Interventionelle Radiologie

    Heidelberg, 69126

  • Universitätsklinikum des Saarlandes, Klinik für Diagnostische und Interventionelle Radiologie

    Homburg, 66421

  • Universitätsklinikum Schleswig Holstein, Klinik für Diagnostische Radiologie, Campus Kiel

    Kiel, 24105

  • Universitätsklinikum Leipzig, Department für Bildgebung und Strahlenmedizin

    Leipzig, 04103

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

    Marburg, 35043

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

    München, 80336

  • Klinikum der Universität Muenchen, Institut für Klinische Radiologie

    München, 81377

  • Klinikum Nord-Nuernberg, Radiologie

    Nuremberg, 90419

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Keywords
MRI, COPD
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02629432
Study groupRoleWhat they receive
Cosyconet COPD CohortMRI and CT of the lung will be performed in a multi-centre cohort of 625 COPD-patients from the main COSYCONET cohort.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: single time point/baseline only

Secondary outcomes (4)

  1. 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

    Measured: single time point/baseline only

  2. 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

    Measured: single time point/baseline only

  3. 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

    Measured: single time point/baseline only

  4. 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

    Measured: single time point/baseline only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2015 (estimated)
  2. Study startDec 2013
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
602 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT02629432
Sponsor's protocol ID
01GI0884
Acronym
MR-COPD
Status last verified
May 2017
First submitted
23 Oct 2015
Last updated
11 May 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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

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.

    PubMed 22695943

  • 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.

    PubMed 22695944

  • 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.

    PubMed 22695952

  • 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.

    PubMed 21429685

  • 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.

    PubMed 22429093

  • 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.

    PubMed 21393027

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by University Hospital Heidelberg at 15 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: single time point/baseline only). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02629432, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in