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

Registry ID
ISRCTN15785949
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
Oxford University Hospitals NHS Trust
Enrollment
60
Start date
2024-06-01
Completion date
2030-05-31
Last update
2026-08-17

Conditions

Summary

The progression of interstitial lung abnormalities into interstitial lung disease

Detailed description

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 clinical pathway for monitoring of ILA's including a baseline CT chest. In addition to routine care, as part of the study, they will have a research Hyperpolarised Xenon MRI (HPX-MRI) after 3 months of consent and another at 24 months post consent. If needed, a repeat CT will also be performed if patient has progressive symptoms or signs of ILD. Control participants will have a baseline CT chest and one HPX-MRI at 3 months post consent. All subjects will also have blood biomarkers sampled at 3 months, 24 months, and 36-42 months post consent for routine bloods and biomarkers. At the baseline visit, 12 months, 24 months, and 36-42 months, study participants will be examined by a clinical research fellow, have their MRCD, KBILD, and frailty scored, have a 6 minute walk test and lung function tests.

Interventions

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

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.

Locations

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