Condition category
Respiratory
Date applied
29/10/2015
Date assigned
17/11/2015
Last edited
16/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) are severe diseases which affect the lungs. COPD is known as an obstructive lung disease, as over time the airways become narrowed or blocked. IPF is known as a restrictive lung disease, as it causes scar tissue to grow inside the lungs, preventing them from expanding fully. Although clinically different, these two diseases cause shortness of breath which is worse when the sufferer exerts themselves. Currently, the main ways to diagnose COPD and IPF are by using lung function tests (breathing tests to measure how much air they are breathing in and out), and CT scanning (a scan which uses X-rays and a computer to create detailed images of inside the body). However, lung function tests only show how well the lungs are working as a whole and CT scanning is risky as it exposes patients to potentially damaging radiation. MRI scanning is a type of scan which uses strong magnetic fields and radio waves to produce a detailed picture of the inside of the body. This type of procedure is less risky than a CT scan but is not able to produce as detailed a picture of the lungs. Xenon (129Xe) is an unreactive gas which is plentiful in the atmosphere. Studies have shown that when it is hyperpolarised (making it more negatively charged), it dissolves in the body’s tissues and can show how well the blood and air are moving in the lungs on an MRI scan. The aim of this study is to find out if using hyperpolarised 129Xe and MRI scanning is a reliable way of testing lung function.

Who can participate?
Adults who able to hold their breath for 10 seconds, and are either healthy or suffering from COPD or IPF.

What does the study involve?
Participants are divided into three groups: those suffering from COPD, those suffering from IPF and healthy volunteers. At the start of the study, all participants attend a screening visit where they have their lungs and hearts tested to see if they are suitable to take part in the study. The patients who are able to take part then attend a second visit. At this visit, participants are asked to inhale (breathe in) 1 litre of non-polarised xenon (neutral). They then go into the MRI scanner and inhale 1 litre of hyperpolarised xenon while they are scanned. During this time, the amount of oxygen in the blood and their heart rate is measured. This process is repeated three times during the visit. Participants in the healthy volunteers group are invited to an optional follow up session where the scan is repeated (without the non-polarised xenon inhalation step). A selection of participants from each group is asked to attend several more visits in order to repeat the scan so the reliability of the results can be measured.

What are the possible benefits and risks of participating?
There is no direct benefit of taking part in the study. There are no notable risks of taking part, however there is a small risk that some participants may experience claustrophobia during MRI.

Where is the study run from?
Medical Imaging Unit, University of Nottingham Medical School (UK)

When is the study starting and how long is it expected to run for?
December 2013 to December 2017

Who is funding the study?
University of Nottingham (UK)

Who is the main contact?
Professor Ian Hall

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ian Hall

ORCID ID

Contact details

Department of Respiratory Medicine (QMC)
D Floor South Block
Queen’s Medical Centre
Nottingham
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

2013-004336-30

ClinicalTrials.gov number

Protocol/serial number

13104

Study information

Scientific title

Functional magnetic resonance lung imaging using inhaled hyperpolarised 129xenon in healthy volunteers, patients with chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF)

Acronym

Study hypothesis

This study aims to assess hyperpolarised 129Xe MRI as an imaging modality in patients with COPD and IPF, and to compare the data to other markers of disease severity, namely lung function test.

Ethics approval

NRES Committee East Midlands - Nottingham, 31/12/2013, ref: 13/EM/0401

Study design

Single-centre case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

1. Chronic obstructive pulmonary disease (COPD)
2. Idiopathic pulmonary fibrosis (IPF)

Intervention

There are three groups of participants: healthy volunteers, patients with COPD and patients with IPF.

Screening visit
At the screening visit, the trial procedure is explained to the potential participants, and informed consent obtained. Thereafter, they will undergo physical examination, lung function test, and ECG to ensure they are eligible to participate. If deemed eligible, they will be invited for the first study visit. The screening visit is expected to take up to 90 minutes.

First Study visit
At the first study visit, after monitoring vital signs, and MRI check list, the participant will initlally be given 1L non-polarised xenon to inhale in a clinical area to monitor for side effects. If side effect free, they will enter the MRI scanner, asked to inhale up to 1L hyperpolarised xenon, and MR images are obtained. Oxygen saturations and heart rate will be monitored while the patient is in the scanner, and this wiil not last more than 20 minutes. After an observation period of 30 minutes, this process will be repeated up to 3 more times, with the participant monitored for at least 30 minutes after each scan. They will receive a phone call 24 hours afterwards to monitor wellbeing. The study visit is expected to take up to 5-6 hours.

Second study visit
This is only applicable to healthy volunteers, and is optional. The procedure is the same as the first study visit, but excludes the inhalation of non-polarised xenon. The study visit is expected to take up to 5-6 hours.

Follow up study visit
After at least a week, where participants have consented to being contacted for follow up studies, they may be contacted for follow up scans to assess repeatability of measurements. Participants will not be asked to attend more than 3 study visits in total. The study visit is expected to take up to 5-6 hours.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Pattern of spontaneously resolving ventilation defects measured using 129Xe MRI lung imaging completed over a four week period
2. Estimates of lung volumes measured using 129Xe MRI lung imaging completed over a four week period

Secondary outcome measures

1. Compare 129Xe MRI-obtained lung function parameters with matched clinical data e.g. (pulmonary function tests) over a 4-week period, allowing comparison with existing clinical diagnostic techniques and determining correlation with disease severity
2. Use the images obtained to set up standard sequencing protocols and define algorithms and inform power calculations for subsequent studies

Overall trial start date

31/12/2013

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

General inclusion criteria:
1. Aged 18 years or over
2. Capacity to give informed consent
3. Normal blood pressure (systolic BP > 100 mmHg and diastolic BP > 70 mmHg)
4. Resting heart rate > 50 bpm
5. For women, negative urinary β-hCG at the screening and subsequent visits
6. Subject able to hold breath for 10 seconds
7. Subject able to fit into 129Xe chest coil used for MRI
8. Subject able to understand the requirements of the study and to cooperate with the study procedures

Healthy volunteer inclusion criteria:
No significant respiratory disease within the last year

COPD patient inclusion criteria:
1. Evidence of airflow obstruction (FEV/FVC <0.7) and FEV1 <80% predicted post bronchodilator
2. Minimum FVC 1.5L

IPF patient inclusion criteria:
1. Diagnosis of IPF by high resolution CT scan
2. Full pulmonary function test performed within 12 months prior to imaging
3. Minimum FVC 1.5L

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

50 for each participant group.

Participant exclusion criteria

Healthy volunteer exclusion criteria:
1. Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
2. Acute respiratory illness within 30 days of MRI
3. Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
4. Subject deemed unlikely to comply with instructions during imaging
5. Do not meet the inclusion criteria above
6. Subject not deemed fit enough to tolerate procedure
7. Subject deemed unsuitable by clinical investigator for other reasons

COPD and IPD patient exclusion criteria:
1. Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
2. Acute respiratory illness within 30 days of MRI
3. Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
4. Subject deemed unlikely to comply with instructions during imaging
5. Do not meet the inclusion criteria above
6. Subject not deemed fit enough to tolerate procedure
7. Subject deemed unsuitable by clinical investigator for other reasons

Recruitment start date

01/03/2015

Recruitment end date

30/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham Medical School
Unit A52 Medical Imaging Unit Queen's Medical Centre Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham

Sponsor details

University Park
Nottingham
NG7 2RD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Nottingham

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Intention to present the preliminary safety data at the European Respiratory Society (ERS) 2016 conference in London in September 2016. The study results will also be submitted for publication in a peer reviewed journal.

Intention to publish date

30/09/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes