Functional and Structural Lung Imaging in Chronic Obstructive Pulmonary Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-08-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Alpha 1-Antitrypsin Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Adult healthy volunteers

Adult healthy volunteers, age matched to patient volunteers. Will undergo a combination of functional and structural lung MRI scans.

Lung MRI scan

Intervention Type DIAGNOSTIC_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.

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.

Lung MRI scan

Intervention Type DIAGNOSTIC_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.

Adults with alpha-1-antitrypsin deficiency

Will undergo a combination of functional and structural lung MRI scans.

Lung MRI scan

Intervention Type DIAGNOSTIC_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.

Interventions

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Lung MRI scan

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

* 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

Exclusion Criteria

* 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

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes