Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT02629432
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2015-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 602}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2015-10-23', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'single time point/baseline only', 'description': 'diagnostic study, MRI and CT acquired on the same day'}], 'secondaryOutcomes': [{'measure': 'number of completed examinations with diagnostic image quality to determine the achievable diagnostic quality of lung MRI in a multi-center setting', 'timeFrame': 'single time point/baseline only', 'description': 'to assess the achievable image quality in a multicentre setting'}, {'measure': 'agreement of visual and software-based phenotyping on MRI and CT (airway wall thickening, air trapping, emphysema, lung perfusion deficits)', 'timeFrame': 'single time point/baseline only', 'description': 'to compare both modalities for the assessment of those parameters'}, {'measure': '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)', 'timeFrame': 'single time point/baseline only', 'description': 'to assess the value of MRI-based biomarkers in comparison to clinical data'}, {'measure': 'number of cases in which MRI (i.e. functional parameters) produces clinically relevant additional information to CT', 'timeFrame': 'single time point/baseline only', 'description': 'to assess potential advantages of MR compared to CT'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MRI', 'COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '22695943', 'type': 'BACKGROUND', 'citation': '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': '22695944', 'type': 'BACKGROUND', 'citation': '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': '22695952', 'type': 'BACKGROUND', 'citation': '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': '21429685', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22429093', 'type': 'BACKGROUND', 'citation': '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': '21393027', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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) .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The population to be studied is determined by the main Cosyconet-cohort.\n\nKey inclusion criteria:\n\n* being included into the main cohort\n* diagnosis of COPD (GOLD criteria)\n* availability for repeated study visits\n* male or female\n* age \\> 40 years\n\nExclusion Criteria:\n\n* Key exclusion criteria as determined by the main Cosyconet-cohort:\n* having undergone lung surgery (e.g., lung volume reduction, lung transplant)\n* moderate or severe exacerbation within the last 4 weeks prior to visit 1\n* unable to understand the intention of the project\n* lack of signed patient informed consent\n* contraindications for MRI\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02629432', 'acronym': 'MR-COPD', 'briefTitle': 'Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR COPD)', 'orgStudyIdInfo': {'id': '01GI0884'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cosyconet COPD Cohort', 'description': 'MRI and CT of the lung will be performed in a multi-centre cohort of 625 COPD-patients from the main COSYCONET cohort.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitätsklinikum, Diagnostische und Interventionelle Radiologie und Neuroradiologie', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Universitätsklinikum Gießen und Marburg GmbH,Klinik für Diagnostische und Interventionelle Radiologie', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '17475', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'Universitätsmedizin Greifswald, Institut für Diagnostische Radiologie u. Neuroradiologie', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'zip': '22927', 'city': 'Großhansdorf', 'country': 'Germany', 'facility': 'LungenClinic Grosshansdorf, Pneumologisches Forschungsinstitut', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'zip': '20354', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Hamburger Institut für Therapieforschung (HIT) GmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover, Zentrum Radiologie, Institut für Diagnostische und Interventionelle Radiologie', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg, Diagnostische und Interventionelle Radiologie', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik Heidelberg, Diagnostische und Interventionelle Radiologie', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '66421', 'city': 'Homburg', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes, Klinik für Diagnostische und Interventionelle Radiologie', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig Holstein, Klinik für Diagnostische Radiologie, Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig, Department für Bildgebung und Strahlenmedizin', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '35043', 'city': 'Marburg', 'country': 'Germany', 'facility': 'Universitätsklinikum, Zentrum für Radiologie, Klinik für Diagnostische und Interventionelle Radiologie', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'Institut für Klinische Radiologie, Klinikum der Universität Muenchen (KUM), Campus Innenstadt Muenchen', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '81377', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum der Universität Muenchen, Institut für Klinische Radiologie', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '90419', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Klinikum Nord-Nuernberg, Radiologie', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}], 'overallOfficials': [{'name': 'Juergen Biederer, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Heidelberg'}, {'name': 'Bertram Jobst, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Heidelberg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philipps University Marburg', 'class': 'OTHER'}, {'name': 'Hannover Medical School', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Prof. Dr. Juergen Biederer', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}