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Completed

NCT Number: NCT02629432

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum, Diagnostische und Interventionelle Radiologie und Neuroradiologie, Essen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: single time point/baseline only

    diagnostic study, MRI and CT acquired on the same day

Secondary outcomes

  1. 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

    to assess the achievable image quality in a multicentre setting

  2. 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

    to compare both modalities for the assessment of those parameters

  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)

    Time frame: single time point/baseline only

    to assess the value of MRI-based biomarkers in comparison to clinical data

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

    Time frame: single time point/baseline only

    to assess potential advantages of MR compared to CT

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • Hannover Medical School
  • Philipps University Marburg

Registry information

Official study title

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

Acronym: MR-COPD

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 14, 2015
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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