Chronic Obstructive Pulmonary DiseaseFASTCOPDNCT04966221
Functional and Structural Lung Imaging in Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Alpha 1-Antitrypsin Deficiency, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Alpha 1-Antitrypsin Deficiency
- What is being tested?
- Lung MRI scan
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2022to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Workstream 1 Inclusion criteria (Adult Healthy Volunteers)
- Male or female aged 18 years and over
- Capacity to give informed consent
- Normal blood pressure (systolic BP > 90 mmHg and diastolic BP >50 mmHg)
- Resting heart rate > 50bpm
- For women, negative urinary β-hCG at the screening and subsequent visits (where clinical uncertainty of pregnancy)
- Subject able to hold breath for 10 seconds
- Subject able to understand the requirements of the study and to cooperate with the study procedures
- Subject has normal lung function by spirometry criteria
- Smoking history of > 10 pack years of tobacco smoking
Workstream 1 Exclusion criteria (Adult Healthy Volunteers)
- Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
- Subject deemed unlikely to comply with instructions during imaging
- Subject not deemed fit enough to tolerate procedure
- Subject deemed unsuitable by clinical investigator for other reasons
- Abnormal spirometry
Workstream 2 Inclusion criteria (Adults with chronic obstructive pulmonary disease)
- Male or female aged 18 years and over
- Capacity to give informed consent
- Normal blood pressure (systolic BP > 90 mmHg and diastolic BP >50 mmHg)
- Resting heart rate > 50bpm
- For women, negative urinary β-hCG at the screening and subsequent visits (where clinical uncertainty of pregnancy)
- Subject able to hold breath for 10 seconds
- Subject able to understand the requirements of the study and to cooperate with the study procedures
- Diagnosis of COPD made by respiratory physician and confirmed by spirometry criteria (FEV1/FVC ratio < 0.7) and > 10 pack years of tobacco smoking.
Workstream 2 Exclusion criteria (Adults with chronic obstructive pulmonary disease)
- Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
- Acute illness considered to be of sufficient severity to prevent safe MRI scanning. In this instance, the subject will be invited to be rescreened > 4 weeks later.
- Subject deemed unlikely to comply with instructions during imaging
- Subject not deemed fit enough to tolerate procedure
- Subject deemed unsuitable by clinical investigator for other reasons
Workstream 3 Inclusion criteria (Adults with COPD due to alpha-1-antitrypsin deficiency - A1ATD)
- Male or female aged 18 years and over
- Capacity to give informed consent
- Normal blood pressure (systolic BP > 90 mmHg and diastolic BP >50 mmHg)
- Resting heart rate > 50bpm
- For women, negative urinary β-hCG at the screening and subsequent visits (where clinical uncertainty of pregnancy)
- Subject able to hold breath for 10 seconds
- Subject able to understand the requirements of the study and to cooperate with the study procedures
- Diagnosis of A1ATD (PiZZ or PiZ-) and either evidence of emphysema on a previous clinical CT scan or evidence of airways obstruction
Workstream 3 Exclusion criteria (Adults with COPD due to alpha-1-antitrypsin deficiency - A1ATD)
- Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
- Acute illness considered to be of sufficient severity to prevent safe MRI scanning. In this case, the subject will be rescreened >4 weeks later
- Subject deemed unlikely to comply with instructions during imaging
- Subject not deemed fit enough to tolerate procedure
- Subject deemed unsuitable by clinical investigator for other reasons
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Sir Peter Mansfield Imaging Centre, University of Nottingham
Nottingham, Nottinghamshire, NG7 2QX
Richard Bowtell, PhD, richard.bowtell@nottingham.ac.uk
About this study
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).
Read the detailed description
This is a single centre pilot study. The research team aims to recruit adult healthy volunteers and adult patient volunteers with COPD and A1ATD. We have used similar proton-based MRI techniques in healthy volunteers and people with other lung diseases and the MRI scans have been well tolerated.
All participants will be adults (both male and female) who can give informed consent and are able to undertake the study procedures. Potential participants who cannot have an MRI scan for safety reasons (e.g. have a pacemaker) will not be recruited. During study visits, all research activities will be observed by a member of the research team.
During the screening visit (following consent), the following information and measures will be taken:
Relevant past medical history, COPD assessment tool (questionnaire), height, weight, blood pressure and pulse oximetry.
During study visits, a combination of structural and functional lung MRI scans will be performed with the participant lying in the scanner. Participants will be asked to breathe normally during scans and may also be asked to perform breathing manoeuvres such as holding their breath temporarily.
The participants will be assigned unique codes, and their data will be anonymised. Participants' medical reports will only be accessed for study purposes and will be treated as confidential.
The investigators will aim to use the data to plan future studies, and the data from this study may contribute to publications and presentations. Participants will not be identified in any publications arising from the research. The data obtained will be published without any identifying information.
- Being tested
- Lung MRI scan
- Keywords
- MRI, COPD, A1ATD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, alpha 1-Antitrypsin Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung MRI scanDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult healthy volunteers | Adult healthy volunteers, age matched to patient volunteers. Will undergo a combination of functional and structural lung MRI scans. Receives: Diagnostic Test: Lung MRI scan | |
| Adults with Chronic Obstructive Pulmonary Disease | 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. Receives: Diagnostic Test: Lung MRI scan | |
| Adults with alpha-1-antitrypsin deficiency | Will undergo a combination of functional and structural lung MRI scans. Receives: Diagnostic Test: Lung MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (3)
To assess the ability of participants of each group to adhere to the protocols, thus informing the study design of future trials
Measured: 3 years
To assess any change of MR outcomes across study visits for those participants undertaking more than one MR scanning visit.
Measured: 3 years
To assess any change of MR outcomes across study visits for participants who undergo LVR
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Jan 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Responsible party
- Principal investigator, Jonathan Brooke, University of Nottingham
- Investigators
- Jonathan Philip Brooke, Principal investigator, The University of NottinghamZachary Peggs, Principal investigator, The University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966221
- Sponsor's protocol ID
- 21048
- Acronym
- FASTCOPD
- Status last verified
- May 2022
- First submitted
- 7 Jul 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Structural Lung Imaging in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04966221
- Acronym / sponsor ID
- FASTCOPD / 21048
- Keywords
- MRI, COPD, A1ATD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a single centre pilot study. The research team aims to recruit adult healthy volunteers and adult patient volunteers with COPD and A1ATD. We have used similar proton-based MRI techniques in healthy volunteers and people with other lung diseases and the MRI scans have been well tolerated.
All participants will be adults (both male and female) who can give informed consent and are able to undertake the study procedures. Potential participants who cannot have an MRI scan for safety reasons (e.g. have a pacemaker) will not be recruited. During study visits, all research activities will be observed by a member of the research team.
During the screening visit (following consent), the following information and measures will be taken:
Relevant past medical history, COPD assessment tool (questionnaire), height, weight, blood pressure and pulse oximetry.
During study visits, a combination of structural and functional lung MRI scans will be performed with the participant lying in the scanner. Participants will be asked to breathe normally during scans and may also be asked to perform breathing manoeuvres such as holding their breath temporarily.
The participants will be assigned unique codes, and their data will be anonymised. Participants' medical reports will only be accessed for study purposes and will be treated as confidential.
The investigators will aim to use the data to plan future studies, and the data from this study may contribute to publications and presentations. Participants will not be identified in any publications arising from the research. The data obtained will be published without any identifying information.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adult healthy volunteers | – | Diagnostic Test: Lung MRI scanAdult healthy volunteers, age matched to patient volunteers. Will undergo a combination of functional and structural lung MRI scans. |
| Adults with Chronic Obstructive Pulmonary Disease | – | Diagnostic Test: Lung MRI scanWill 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. |
| Adults with alpha-1-antitrypsin deficiency | – | Diagnostic Test: Lung MRI scanWill undergo a combination of functional and structural lung MRI scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung MRI scanParticipants 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. | Diagnostic test | Adult healthy volunteers, Adults with Chronic Obstructive Pulmonary Disease, Adults with alpha-1-antitrypsin deficiency |
Primary outcome
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
Time frame: 3 years
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 secondary outcomes
To assess the ability of participants of each group to adhere to the protocols, thus informing the study design of future trials
Time frame: 3 years
To assess any change of MR outcomes across study visits for those participants undertaking more than one MR scanning visit.
Time frame: 3 years
To assess any change of MR outcomes across study visits for participants who undergo LVR
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Philip Brooke principal investigator
The University of Nottingham
Zachary Peggs principal investigator
The University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Alpha 1-Antitrypsin Deficiency, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Philip Brooke (01158231154, jonathan.brooke@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.