Imaging Disease Progression in COPD

Imaging Disease Progression in COPD - MR-COPD II

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00014715

Enrollment

370

Registered

2018-06-06

Start date

2017-11-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J44

Interventions

Group 1: 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

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Inclusion criteria

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”)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
• 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.	—

Measure

Time frame

• 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

Germany

Contacts

Public ContactKerstin Burmester

Universitätsklinikum Heidelberg, Klinik Diagnostische und Interventionelle Radiologie

office.imaging@asconet.net06221-56-38741

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026