Functional and Structural Lung Imaging in Chronic Obstructive Pulmonary Disease

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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

August 1, 2021

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]



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

July 2021