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Investigating the use of a novel imaging technique to identify early fibrotic lung disease

Risk stratification of interstitial lung abnormalities using hyperpolarised xenon MRI and blood biomarkers

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN15785949
Enrollment
60
Registered
2024-08-27
Start date
2024-06-01
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The progression of interstitial lung abnormalities into interstitial lung disease Respiratory

Interventions

We aim to recruit 50 study participants, between the ages of 50 and 85, with pre-existing ILA diagnosed within the last 2 years, and 10 healthy volunteers. Study participants will follow routine clini

Sponsors

Oxford University Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study. 2. Male or Female, aged over 18 and under 85 years of age 3. Investigators are of the opinion that the participant is able and willing to comply with the study requirements 3.1. Lung function tests that are normal or near normal – FVC and TLCO >70% predicted for age and gender 3.2. CT imaging fulfils criteria for ILA – 3.2.1. Incidental identification of non-dependent abnormalities on Chest CT, including ground glass or reticular abnormalities, lung distortion, traction bronchiectasis and honeycombing 3.2.2. Occupying up to 10% of the lung as agreed independently by two consultant thoracic radiologists

Exclusion criteria

Exclusion criteria: 1. Unable to provide informed consent 2. Contraindication to MRI e.g. shrapnel injury, heavily tattooed, severe claustrophobia 3. Any significant disease or disorder which, in the opinion of the investigator, might influence the interpretation of the clinical data e.g. Significant co-pathology (e.g. emphysema, poorly controlled asthma, heart failure, pulmonary thromboembolic disease, Covid-19 condition, pneumotoxic agents resulting in lung damage) 4. Clinical frailty score of 6 or above 5. Female participant who is pregnant, lactating or planning pregnancy.

Design outcomes

Primary

MeasureTime frame
To determine whether HPX-MRI abnormalities are detectable in ILAs outwith areas of abnormality visible on CT and to determine whether the presence of functional abnormalities detectable at baseline HPX-MRI correlate with radiological progression of ILAs and/or lung function decline a 1 litre breath hold low dose CT at baseline will be compared with a Hyperpolarised xenon MRI at baseline, and 4 years. Additional low dose CT scans will be taken if the patient shows evidence of progression via symptoms or lung function decline.

Secondary

MeasureTime frame
Current key secondary outcome(s) as of 03/03/2026: Measurement of selected serum biomarkers and analysis of immune cell characteristics in ILAs to see if there are differences that increase or decrease risk of developing ILD , by analysing blood biomarkers at baseline, 2 years, and 3.5-4 years _____ Previous key secondary outcome(s): Measurement of selected serum biomarkers in ILAs to see if baseline levels correlate with risk of developing ILD, by analysing blood biomarkers at baseline, 2 years, and 3.5-4 years

Countries

England, United Kingdom

Contacts

Public ContactNeda Hasan
neda.hasan@ouh.nhs.uk+44 1865 225252

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 30, 2026