Brief Title
Functional and Structural Lung Imaging in Chronic Obstructive Pulmonary Disease
Official Title
Functional and Structural Lung Imaging in Chronic Obstructive Pulmonary Disease
Brief 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). 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 Type
Observational
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
Secondary Outcome
To assess the ability of participants of each group to adhere to the protocols, thus informing the study design of future trials
Condition
Chronic Obstructive Pulmonary Disease
Intervention
Lung MRI scan
Study Arms / Comparison Groups
Adult healthy volunteers
Description: Adult healthy volunteers, age matched to patient volunteers. Will undergo a combination of functional and structural lung MRI scans.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
75
Start Date
January 1, 2022
Completion Date
August 1, 2024
Primary Completion Date
August 1, 2024
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jonathan Philip Brooke, 01158231154, [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT04966221
Organization ID
21048
Responsible Party
Principal Investigator
Study Sponsor
University of Nottingham
Collaborators
Nottingham University Hospitals NHS Trust
Study Sponsor
Jonathan Philip Brooke, Principal Investigator, The University of Nottingham
Verification Date
May 2022