Imaging Progression of Chronic Obstructive Pulmonary Disease Using MRI and CT (MR-COPDII)

NCT03591562 | Completed DMC

• 1 other identifier: 82DZLS24A1
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 10

Brief Summary

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", NCT (clinical.Trials.gov identifier) 02629432). The objective is to obtain longitudinal data from a well-characterized collective of COPD patients in order to identify suitable image-based biomarkers to improve the prognosis of disease progression of COPD in comparison to clinical tests

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

MRI; COPD; Disease Progression

Outcome Measures

Primary Outcomes (6)

• Sensitivity and specificity of pulmonary blood flow calculated from first pass perfusion MRI to predict disease progression in COPD

  Changes from baseline in MRI-based lung perfusion: pulmonary blood flow (PBF)

  Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020

• Sensitivity and specificity of pulmonary blood volume calculated from first pass perfusion MRI to predict disease progression in COPD

  Changes from baseline in MRI-based lung perfusion: pulmonary blood volume (PBV)

  Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020

• Sensitivity and specificity of visual perfusion deficit on first pass perfusion MRI to predict disease progression in COPD

  Changes from baseline in MRI-based lobar perfusion deficit score (visual 4-point rating scale: 0=normal perfusion, 1= mild heterogeneities, 2= perfusion defects affecting up to 50% of a lobe, 3= perfusion defects affecting more than 50% of the lobe). Lobar scores are summed up to a total perfusion deficit score for each patient. A completely healthy subject with unimpared lung perfusion would be scored as "0" (best possible result), while the result for more than 50% involvement of all lung lobes would be scored as "18" (worst possible result).

  December 2013-July 2016 Follow-Up: November 2017-June 2020

• Sensitivity and specificity of airway wall metrics on CT to predict disease progression in COPD

  Changes from baseline in CT-based metrics for the extent of airway wall thickening (standardized airway wall thickness: PI10)

  Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020

• Sensitivity and specificity of emphysema quantification with CT to predict disease progression in COPD

  Changes from baseline in CT-based metrics for the extent of emphysema (low attenuation areas in percent of total lung volume: LAA%)

  Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020

• Sensitivity and specificity of air trapping on expiratory CT to predict disease progression in COPD

  Changes from baseline in CT-based metrics for the extent air trapping (expiratory to inspiratory ratio of mean lung density (E/I-MLD)

  Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020

Study Arms (1)

COSYCONET COPD Subcohort

MRI and CT of the lung will be performed in a multi-centre subcohort of 370 patients having already participated in the precursor trial " Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR-COPD)", NCT 02629432.

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The trial is fully embedded in the COSYCONET cohort and will only comprise participants of the precursor trial performed between 2013 and 2016:Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR-COPD), NCT 02629432.

You may qualify if:

• Patients enrolled into the COSYCONET main cohort (Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis, Utilisation of Health care resources in Patients with COPD (COSYCONET), NCT01245933), having already successfully participated in the COSYCONET subtrial with CT and MRI performed between December 2013 and July 2016 (Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR-COPD), NCT 02629432)

You may not qualify if:

• Insufficient quality of MRI and CT obtained at baseline (MR-COPD I)
• Having undergone lung surgery (e.g. lung volume reduction, lung transplantation)
• Moderate or severe exacerbation requiring antibiotic treatment within prior to appointment
• Absence of consent
• Inability to understand the intention of the project
• Contraindications to MRI and/or CT

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Philipps University Marburg: collaborator
• Hannover Medical School: collaborator
• German Center for Lung Research: collaborator

Study Sites (10)

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

Thoraxklinik Heidelberg, Diagnostische und Interventionelle Radiologie

Heidelberg, 69126, Germany

Location

Universitätsklinikum Schleswig Holstein, Klinik für Diagnostische Radiologie, Campus Kiel

Kiel, 24105, Germany

Location

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

Marburg, 35043, Germany

Location

Klinikum der Universität Muenchen, Klinik und Poliklinik für Radiologie

München, 81377, Germany

Location

Klinikum Nord-Nuernberg, Radiologie

Nuremberg, 90419, Germany

Location

Related Publications (7)

• 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

• 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

• Karch A, Vogelmeier C, Welte T, Bals R, Kauczor HU, Biederer J, Heinrich J, Schulz H, Glaser S, Holle R, Watz H, Korn S, Adaskina N, Biertz F, Vogel C, Vestbo J, Wouters EF, Rabe KF, Sohler S, Koch A, Jorres RA; COSYCONET Study Group. The German COPD cohort COSYCONET: Aims, methods and descriptive analysis of the study population at baseline. Respir Med. 2016 May;114:27-37. doi: 10.1016/j.rmed.2016.03.008. Epub 2016 Mar 11.

  PMID: 27109808 BACKGROUND

• Jorres RA, Welte T, Bals R, Koch A, Schnoor M, Vogelmeier C. [Systemic manifestations and comorbidities in patients with chronic obstructive pulmonary disease (COPD) and their effect on clinical state and course of the disease--an overview of the cohort study COSYCONET]. Dtsch Med Wochenschr. 2010 Mar;135(10):446-9. doi: 10.1055/s-0030-1249185. Epub 2010 Mar 2. German.

  PMID: 20198540 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Disease Progression

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, Prof

  University Hosital Heidelberg

  PRINCIPAL INVESTIGATOR

• Bertram J. Jobst, MD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 17, 2018
• First Posted: July 19, 2018
• Study Start: November 10, 2017
• Primary Completion: December 31, 2019
• Study Completion: April 30, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 12 months after data completion
• Access Criteria: Data access requests by scientists, members or non-members of the COSYCONET consortium, will be reviewed by the COSYCONET Executive Board.

Locations

DE (10)