Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00014715

Trial Description

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Title

Imaging Disease Progression in COPD

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Trial Acronym

MR-COPD II

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this follow-up trial, MRI and CT images of the lung will be acquired prospectively in a subcohort of 370 patients, three years after they successfully participated in the first COSYCONET subtrial with CT and MRI (“MR-COPD I”).
The objective is to obtain longitudinal data from a well-characterized collective of COPD (Chronic Obstructive Pulmonary Disease) patients in order to determine the diagnostic value of CT and functional MRI for the monitoring of disease progression and to evaluate the prognostic value of image-based biomarkers.

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Brief Summary in Scientific Language

The primary goal of this trial is to identify and evaluate the diagnostic value of suitable image-based biomarkers to improve the prognosis of disease progression of COPD in comparison to clinical tests. In conjunction with the data obtained in MR-COPDI, quantitative software-based analysis of CT (density-based evaluation of air-trapping, airway- and emphysema parameters, e.g. PI10, LAA%, E/I-MLD) and perfusion MRI (e.g. pulmonary blood volume (PBV) and pulmonary blood flow (PBF)) will be available for a three year interval. These will be correlated with clinical parameters measured at the time of the second imaging acquisition and the again following three years. A progression of the disease is defined as an increase of the multidimensional 10-point BODE index by at least one point.

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Organizational Data

  •   DRKS00014715
  •   2018/06/06
  •   [---]*
  •   yes
  •   Approved
  •   S-400/2016, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

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

  •   370 patients enrolled into the COSYCONET cohort of COPD patients and having already participated successfully in the first trial with CT and MRI carried out within the COSYCONET subproject 7 between 2013 and 2016 (DRKS00005072, NCT02629432), are invited to attend the respective COSYCONET study center for a second assessment by MRI and CT.
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Characteristics

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

Identification of suitable image-based biomarkers to improve the prognosis of disease progression of COPD (Chronic Obstructive Pulmonary Disease) in comparison to clinical tests:
• Use of the image-based assessment of the course of COPD: changes in lung perfusion MRI (e.g. PBV, PBF) and CT (e.g. PI10, LAA%, E/I-MLD) within a 3-year interval for the prediction of long-term disease progression as monitored by clinical tests (within the following 3 years; BODE index) . A progression of the disease is defined as an increase of the multidimensional 10-point BODE index by at least one point.

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Secondary Outcome

• Predictive value of image-based quantitative biomarkers (changes in lung perfusion MRI (e.g. PBV, PBF) and CT (e.g. PI10, LAA%, E/I-MLD)) within the 3-year interval for rapid progression of COPD in comparison to clinical tests (BODE index, 3 and 6 year interval).
• Comparative analysis of image-based quantitative biomarkers (lung perfusion MRI, Air-trapping, airway- and emphysema metrics derived from CT) with established clinical biomarkers (BODE Index) for the quantitative evaluation of disease progression after 3 years (correlation of image - based biomarkers with clinical biomarkers over the same 3 year interval)
• Comparative analysis of image-based quantitative biomarkers (lung perfusion MRI, Air-trapping, airway- and emphysema parameters from CT) acquired during short-term interval (3-year interval) and established clinical biomarkers (BODE index) during long-term interval (6-year interval) for the quantitative evaluation of disease progression.
• Predictive value of image-based phenotypes (airway predominant or emphysema predominant phenotype) for the prognosis of COPD.
• Impact of tobacco consumption on structural and functional lung characteristics (quantitative lung perfusion MRI, air trapping, airway- and emphysema parameters from CT).
• Impact of frequent exacerbations on structural and functional lung characteristics in comparison to an exacerbation-free course of COPD.
• Establishment of an optimized MRI protocol for the monitoring of disease progression in COPD within a clinical context.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2017/11/10
  •   370
  •   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

• Patients enrolled into the COSYCONET main cohort of COPD (Chronic Obstructive Pulmonary Disease) patients, having already participated in the COSYCONET subtrial with CT and MRI performed between December 2013 and July 2016 (“MR-COPD I”, COSYCONET Subproject 7);
• MRI and CT images obtained in sufficient quality at baseline (“MR-COPD-I”)

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Exclusion Criteria

• Having undergone lung surgery (e.g. lung volume reduction, lung transplantation)
• Replaced pneumonia (antibiotic treatment necessary) in the last four weeks.
• Moderate or severe exacerbation requiring antibiotic treatment within the last 4 weeks prior to appointment
• Absence of informed consent
• Inability to understand the intention of the project
• Missing or incomplete MRI or CT examination in baseline (MR-COPD I).
• Insufficient quality of MRI and CT obtained at baseline (MR-COPD I)

Contraindications to CT and MRI:
• Due to the strong magnetic field
- patients with pacemaker
- patients with incompatible metallic implants
• Due to the use of Gadolinium based contrast agent
- allergy
- acute and chronic renal insufficiency (GFR <40 ml / min according to MDRD calculation)
• Pregnancy
• Claustrophobia
• Acute psychoses or other conditions that make the perception of the patient appear limited

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Addresses

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    • Universitätsklinikum Heidelberg Klinik Diagnostische und Interventionelle Radiologie
    • Mr. 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg, Klinik Diagnostische und Interventionelle Radiologie
    • Mr.  Dr. med.  Bertram J.  Jobst 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg, Klinik Diagnostische und Interventionelle 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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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Enrolling by invitation
  •   [---]*
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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.