Cystic FibrosisNCT02912637
Hyperpolarized Xenon Imaging in Patients With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Chronic lung diseases show a gradual onset of irreversible lung damage which can lead to severe breathing problems and/or respiratory failure. Imaging is central to guiding treatment; however, current techniques are either inaccurate or involve exposure to radiation. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Hyperpolarized Xenon MRI
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to Mar 2023
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with cystic fibrosis and healthy volunteers
Who may be able to join
- 18 years or above with proven CF, and:
- Clinical stable disease over last month, defined as:
- One month without intravenous antibiotics for airways disease, and:
- One month without evidence for decrease in lung function (no evidenced drop in FEV1 or PEFR >10%).
Who cannot join
- Contraindications to MR (presence of non MR compatible pacemaker, aneurysm clips, artificial heart valves, ear implants, metal fragments or metallic foreign objects in the eyes, pregnancy, and severe claustrophobia),
- Ability to breath hold below 15 seconds.
- Current (> 6 months) smoker
- Volunteer inclusion criteria:
- No history of acute (within the last 6 months) or chronic illness (this will be determined by direct communication with the volunteer and not from their medical records)
- Volunteer exclusion Criteria:
- As patients
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB23 3RE
About this study
Official title: Hyperpolarised 129Xe MRI for Non-invasive Assessment of Ventilation, Perfusion and the Alveolar Membrane - a Physiological Study in Healthy Volunteers & Cystic Fibrosis Patients
Chronic lung diseases show a gradual onset of irreversible lung damage which can lead to severe breathing problems and/or respiratory failure. Imaging is central to guiding treatment; however, current techniques are either inaccurate or involve exposure to radiation. Recent developments in lung magnetic resonance imaging (MRI) provide promise as a radiation-free alternative. However, conventional MRI cannot directly show changes in distribution of inhaled air or absorption of gas which are important signs of early lung disease. Recently MRI imaging of the inhaled gas contrast agent Xenon has been developed which can provide this important information. This study aims to determine how Xenon MRI can help determine air flow distribution and gas uptake in the lungs. The investigators will also be able to compare the information from patients with that from healthy volunteers. This should give insight into the processes involved in chronic lung diseases and help evaluate disease extent in patients.
Read the detailed description
Hyperpolarised gas MRI (3He and 129Xe) has enabled novel methods of in-vivo functional lung imaging that do not rely on the use of ionising radiation. Hyperpolarised 129Xe (HP Xe) MRI provides additional complementary information to 3He and 1H MRI and conventional lung imaging modalities. By virtue of its solubility, the 129Xe contrast agent follows the gas exchange pathways in the lungs, offering a direct means to explore regional ventilation-perfusion (V/Q). The competing modality of nuclear medicine lung V/Q scans suffer from very poor spatial resolution and a reliance on high doses of radiation via radio-nuclide inhalation. Nuclear medicine is thus unsuitable for studies of basic physiology in healthy volunteers or in longitudinal studies in lung disease patients.
The aims and objectives of this study are:
- To assess the physiological differences in lung ventilation between the normal group (volunteers) and the cystic fibrosis disease group
- To evaluate differences in Xe diffusion across the alveolar membrane between the normal group (volunteers) and the cystic fibrosis disease group
- To understand the relationship between the extent of abnormal ventilation (and ventilation-perfusion mismatch) on MRI and the results from conventional physiological evaluation of lung function using pulmonary function tests (spirometry and gas exchange)
- To understand the relationship between gas exchange as determined by HP Xe imaging with the extent of ventilation perfusion mismatch on standard perfusion MRI
This is a physiological cross-sectional feasibility study comparing regional lung ventilation and diffusion across the alveolar membrane in normal volunteers and cystic fibrosis. 15 healthy volunteers and 15 cystic fibrosis patients will be recruited. All imaging will take place at Papworth Hospital.
Phase I: Volunteer study (n=15, aged 18-70)
Hyperpolarised 129Xe MRI scans will be performed in the MRI department at Papworth Hospital, using a Siemens Avanto 1.5 Tesla system with 129Xe capability using a dedicated transmit-receive RF coil.
Phase II: CF study (n=15, aged 18-70)
Patients already enrolled in the study 'Pulmonary magnetic resonance imaging in cystic fibrosis: accuracy and reproducibility' (REC reference: 13/EE/0401; IRAS project ID: 73137) will be invited to take part in this study too.
These patients, with CF in stable phase, will be evaluated with same day conventional MRI, lung function tests and clinical scoring. The methodology of 129Xe MRI will be as described above for healthy volunteers.
Morphological imaging: A combination of T1 and T2 weighted sequences will be used.
Hyperpolarized 129Xe MR imaging: For each subject, up to two deliveries of ≤ 1L doses of hyperpolarised xenon will take place as follows:-
- 129Xe ventilation imaging will provide further information on assessment of lung ventilation volume using a volumetric gradient echo sequence.
- Chemical shift saturation recovery (CSSR) spectroscopy with dissolved xenon will provide an estimation of the fraction of 129Xe in tissue/interstitium and in red blood cells.
- Conditions
- Cystic Fibrosis
- Being tested
- Hyperpolarized Xenon MRI
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Xenon MRIOther
MRI \& MRS of lung using inhaled hyperpolarized Xenon as a contrast agent
| Study group | Role | What they receive |
|---|---|---|
| CF patients | Hyperpolarized Xenon MRI Receives: Other: Hyperpolarized Xenon MRI | |
| Healthy volunteers | Hyperpolarized Xenon MRI Receives: Other: Hyperpolarized Xenon MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ventilation assessed by Percentage Ventilation Defect (VD%)
Quantitative measure of lung ventilation
Measured: 24 hours
Secondary outcomes (5)
Forced expiratory volume (%) in 1 second (FEV1)
Quantitative measure of lung function
Measured: 24 hours
Percentage perfusion defect (PD%)
Quantitative measure of lung perfusion
Measured: 24 hours
Regional ventilation: perfusion (1-VD%)/(1-PD%) ratio
Quantitative measure of regional lung function
Measured: 24 hours
CF Brody score assessed on CT in patient group
Disease severity (in patients) assessed by routine CT
Measured: 24 hours
Percentage ventilation defect assessed on CT (hypoattenuation) - patient group only
Disease severity (in patients) assessed by quantitative measure of ventilation on routine CT
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2023
- Study completionMar 2023
Why it stopped: Technical and administrative problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Nicholas J Screaton, Principal investigator, Papworth NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912637
- Sponsor's protocol ID
- P02215
- Status last verified
- May 2025
- First submitted
- 13 Sep 2016
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarised 129Xe MRI for Non-invasive Assessment of Ventilation, Perfusion and the Alveolar Membrane - a Physiological Study in Healthy Volunteers & Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT02912637
- Acronym / sponsor ID
- P02215
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Technical and administrative problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- University of Sheffield
- Study start
- Oct 2016
- Primary completion
- Mar 2023 (actual)
- Study completion
- Mar 2023 (actual)
- First posted
- 23 Sep 2016 (estimated)
- 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.
Chronic lung diseases show a gradual onset of irreversible lung damage which can lead to severe breathing problems and/or respiratory failure. Imaging is central to guiding treatment; however, current techniques are either inaccurate or involve exposure to radiation. Recent developments in lung magnetic resonance imaging (MRI) provide promise as a radiation-free alternative. However, conventional MRI cannot directly show changes in distribution of inhaled air or absorption of gas which are important signs of early lung disease. Recently MRI imaging of the inhaled gas contrast agent Xenon has been developed which can provide this important information. This study aims to determine how Xenon MRI can help determine air flow distribution and gas uptake in the lungs. The investigators will also be able to compare the information from patients with that from healthy volunteers. This should give insight into the processes involved in chronic lung diseases and help evaluate disease extent in patients.
Detailed description
Hyperpolarised gas MRI (3He and 129Xe) has enabled novel methods of in-vivo functional lung imaging that do not rely on the use of ionising radiation. Hyperpolarised 129Xe (HP Xe) MRI provides additional complementary information to 3He and 1H MRI and conventional lung imaging modalities. By virtue of its solubility, the 129Xe contrast agent follows the gas exchange pathways in the lungs, offering a direct means to explore regional ventilation-perfusion (V/Q). The competing modality of nuclear medicine lung V/Q scans suffer from very poor spatial resolution and a reliance on high doses of radiation via radio-nuclide inhalation. Nuclear medicine is thus unsuitable for studies of basic physiology in healthy volunteers or in longitudinal studies in lung disease patients.
The aims and objectives of this study are:
- To assess the physiological differences in lung ventilation between the normal group (volunteers) and the cystic fibrosis disease group
- To evaluate differences in Xe diffusion across the alveolar membrane between the normal group (volunteers) and the cystic fibrosis disease group
- To understand the relationship between the extent of abnormal ventilation (and ventilation-perfusion mismatch) on MRI and the results from conventional physiological evaluation of lung function using pulmonary function tests (spirometry and gas exchange)
- To understand the relationship between gas exchange as determined by HP Xe imaging with the extent of ventilation perfusion mismatch on standard perfusion MRI
This is a physiological cross-sectional feasibility study comparing regional lung ventilation and diffusion across the alveolar membrane in normal volunteers and cystic fibrosis. 15 healthy volunteers and 15 cystic fibrosis patients will be recruited. All imaging will take place at Papworth Hospital.
Phase I: Volunteer study (n=15, aged 18-70)
Hyperpolarised 129Xe MRI scans will be performed in the MRI department at Papworth Hospital, using a Siemens Avanto 1.5 Tesla system with 129Xe capability using a dedicated transmit-receive RF coil.
Phase II: CF study (n=15, aged 18-70)
Patients already enrolled in the study 'Pulmonary magnetic resonance imaging in cystic fibrosis: accuracy and reproducibility' (REC reference: 13/EE/0401; IRAS project ID: 73137) will be invited to take part in this study too.
These patients, with CF in stable phase, will be evaluated with same day conventional MRI, lung function tests and clinical scoring. The methodology of 129Xe MRI will be as described above for healthy volunteers.
Morphological imaging: A combination of T1 and T2 weighted sequences will be used.
Hyperpolarized 129Xe MR imaging: For each subject, up to two deliveries of ≤ 1L doses of hyperpolarised xenon will take place as follows:-
- 129Xe ventilation imaging will provide further information on assessment of lung ventilation volume using a volumetric gradient echo sequence.
- Chemical shift saturation recovery (CSSR) spectroscopy with dissolved xenon will provide an estimation of the fraction of 129Xe in tissue/interstitium and in red blood cells.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CF patients | – | Other: Hyperpolarized Xenon MRIHyperpolarized Xenon MRI |
| Healthy volunteers | – | Other: Hyperpolarized Xenon MRIHyperpolarized Xenon MRI |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cystic fibrosis and healthy volunteers
Key inclusion criteria (4 listed)
- 18 years or above with proven CF, and:
- Clinical stable disease over last month, defined as:
- One month without evidence for decrease in lung function (no evidenced drop in FEV1 or PEFR >10%).
Key exclusion criteria (7 listed)
- Contraindications to MR (presence of non MR compatible pacemaker, aneurysm clips, artificial heart valves, ear implants, metal fragments or metallic foreign objects in the eyes, pregnancy, and severe claustrophobia),
- Ability to breath hold below 15 seconds.
- Current (> 6 months) smoker
- No history of acute (within the last 6 months) or chronic illness (this will be determined by direct communication with the volunteer and not from their medical records)
- As patients
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 |
|---|---|---|
| Hyperpolarized Xenon MRIMRI \& MRS of lung using inhaled hyperpolarized Xenon as a contrast agent | Other | CF patients, Healthy volunteers |
Primary outcome
Lung ventilation assessed by Percentage Ventilation Defect (VD%)
Time frame: 24 hours
Quantitative measure of lung ventilation
5 secondary outcomes
Forced expiratory volume (%) in 1 second (FEV1)
Time frame: 24 hours
Percentage perfusion defect (PD%)
Time frame: 24 hours
Regional ventilation: perfusion (1-VD%)/(1-PD%) ratio
Time frame: 24 hours
CF Brody score assessed on CT in patient group
Time frame: 24 hours
Percentage ventilation defect assessed on CT (hypoattenuation) - patient group only
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- 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.
Nicholas J Screaton principal investigator
Papworth NHS Foundation Trust
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 Cystic Fibrosis, run by Papworth Hospital NHS Foundation Trust 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?
The sponsor lists 4 inclusion and 7 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 29 May 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung ventilation assessed by Percentage Ventilation Defect (VD%) (time frame: 24 hours). 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 29 May 2025.