NCT04966221|Unknown
Functional and Structural Lung Imaging in Chronic Obstructive Pulmonary Disease
FASTCOPD
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FASTCOPD
Sponsor study identifier
observational
75
1 country
1
Study Start
January 1, 2022
Actual (reported)Primary Completion
August 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study aims to use novel proton-based MRI techniques to assess lung function and structure in healthy volunteers and patients with chronic obstructive pulmonary disease (COPD) and alpha-1-anti-trypsin deficiency (A1ATD). These novel MRI measures will be compared to matched contemporary clinical diagnostic tools, namely pulmonary function tests (PFTs) and computed tomography (CT) scans. MRI has the advantages of avoiding ionising radiation exposure (unlike CT scans) and can also provide regional measures of lung function (unlike PFTs which provide global measures of function). In addition, these MRI techniques do not require the use of any inhaled or injected contrast agents. Some patients enrolled in this study will be undergoing a lung volume reduction (LVR) procedure as part of their normal clinical care. LVR is an intervention for patients with severe lung disease and hyperinflation. It is a palliative therapy that helps to reduce lung hyperinflation through insertion of small valves in the airway or surgical removal of parts of the lung. This can lead to improvements in symptoms such as breathlessness and improve exercise tolerance due to better functioning of the lung. In this study, we will explore how lung MRI measures can be used to assess patients before and after an LVR intervention. This study will take place at the University of Nottingham in collaboration with Nottingham University Hospitals NHS Trust. The study will last for 3 years and participants will be asked to attend a screening visit (lasting up to 1 hour) and either one or two study visits (each lasting up to 3 hours).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2021
Actual (reported)July 19, 2021
Actual (reported)January 1, 2022
Actual (reported)August 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To acquire structural and functional proton-based lung MRI scans from patients with COPD and COPD due to A1ATD and produce baseline data for these groups to inform future clinical studies
To compare functional MRI outcomes with matched clinical physiological data (e.g. pulmonary function tests) To compare structural lung images with matched conventional imaging techniques done for clinical reasons (e.g. computed tomography) of the diaphragm and lungs
3 years
To assess the ability of participants of each group to adhere to the protocols, thus informing the study design of future trials
3 years
To assess any change of MR outcomes across study visits for those participants undertaking more than one MR scanning visit.
3 years
To assess any change of MR outcomes across study visits for participants who undergo LVR
3 years
Adult healthy volunteers, age matched to patient volunteers. Will undergo a combination of functional and structural lung MRI scans.
Will undergo a combination of functional and structural lung MRI scans. Some participants in this cohort will have lung volume reduction (LVR) as part of their normal clinical care. These participants will be given the option to attend two study visits - one before and one after LVR.
Will undergo a combination of functional and structural lung MRI scans.
Participants will have a combination of structural and functional lung MRI scans. These scans will involve lying in a conventional MRI scanner while free breathing and may include additional breathing manoeuvres such as temporarily holding breath.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study population will include up to 25 participants in each of the three workstreams: Workstream 1 - Adult healthy volunteers Workstream 2 - Adults with chronic obstructive pulmonary disease Workstream 3 - Adults with COPD due to alpha-1-antitrypsin deficiency - A1ATD
Sir Peter Mansfield Imaging Centre, University of Nottingham
Nottingham, Nottinghamshire, NG7 2QX, United Kingdom
Jonathan Philip Brooke
The University of Nottingham
Zachary Peggs
The University of Nottingham
First Submitted
July 7, 2021
First Posted
July 19, 2021
Study Start
January 1, 2022
Actual (reported)Primary Completion
August 1, 2024
Estimated (date passed)Study of Relationship Between Changes in Inflammation, Lung Function, Symptoms and Medication Use in COPD Patients
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 24, 2022
Record last verified: 2022-05
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Source: ClinicalTrials.gov.
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