Trial document




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  DRKS00005072

Trial Description

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Title

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

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Trial Acronym

MR COPD

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URL of the Trial

http://www.asconet.net

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Brief Summary in Lay Language

This sub-trial is fully embedded into the competence network of Asthma and COPD (www.asconet.net) and complements the Cosyconet-Study with imaging methods. Up to 625 patients from the Cosyconet-Cohort will be asked to take part. Those patients will be scanned in different study centres once by Lowdose-CT and once by MRI with standardized protocols. The images will be pseudonymized and sent to the Imaging Bank at the University Hospital in Heidelberg where they will be analysed and stored.
The objective of this comparative 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 and that in future it can be used in clinical routine.

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Brief Summary in Scientific Language

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 Lowdose-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.

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Organizational Data

  •   DRKS00005072
  •   2013/07/19
  •   2015/12/14
  •   yes
  •   Approved
  •   S-656/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   NCT02629432  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   J44 -  Other chronic obstructive pulmonary disease
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Interventions/Observational Groups

  •   625 COPD-patients already enclosed in the Cosyconet-Cohort will be scanned in different study centres once by Lowdose-CT and once by MRI with standardized protocols. The images will be pseudonymized and sent to the Imaging Bank at the University Hospital in Heidelberg where they will be analysed and stored.
    The objective of this comparative 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 and that in future it can be used in clinical routine.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary goal of this prospective trial is to demonstrate the capability of MRI to replace CT for the characterization of COPD by “structural and functional phenotyping” on a regional basis. The sensitivity and specificity of MRI will be determined by comparison with CT, serving as the gold standard.

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Secondary Outcome

Secondary endpoints are: Relative frequency of completed MRI examinations with diagnostic quality; agreement of visual and software-based phenotyping; comparative assessment of pulmonary functional reserve by perfusion MRI, pulmonary function tests (TLCO); and the six-minute walk test (6 MWT); and extrapulmonary disease manifestations.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • other 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/12/19
  •   625
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   no maximum age
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Additional Inclusion Criteria

The trial is fully embedded within the main cohort of the COSYCONET-study:

Key inclusion criteria
- Male or female
- Age >40 years
- Diagnosis of COPD (GOLD criteria)
- Available for repeated study visits

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Exclusion Criteria

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 informed consent

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Addresses

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    • Universitätsklinikum Heidelberg Abt. Für Diagnostsiche und Interventionelle Radiologie
    • Mr.  Prof. Dr. med.  Hans-Ulrich  Kauczor 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Phillipps-Universität Marburg Klinik für Innere Medizin mit SP Pneumologie Geschäftsstelle Kompetenznetz Asthma und COPD Studienkoordination
    • Ms.  Dr.  Sandra  Söhler 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    • Philipps-Universität Marburg, Klinik für Innere Medizin mit SP Pneumologie, Leitung der Geschäftsstelle Kompetenznetz Asthma und COPD,
    • Ms.  Inge  Kokot 
    • Baldingerstraße
    • 35043 
    • Germany
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    • Universitätsklinikum Heidelberg Abt. für Diagnostische und Interventionelle Radiologie, Geschäftsführender Oberarzt, Leiter der Sektion Pulmonale Radiologie
    • Mr.  Prof. Dr. med.  Jürgen  Biederer 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg, Klinik für Diagnostische und Interventionelle Radiologie, Sektion Pulmonale Radiologie
    • Ms.  Kerstin  Burmester 
    • Im Neuenheimer Feld 130.3
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • BMBF Bundesministerium für Bildung und Forschung
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/07/07
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.