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

Not Applicable

• Conditions: The progression of interstitial lung abnormalities into interstitial lung disease; Respiratory

• Registration Number: ISRCTN15785949
• Lead Sponsor: Oxford University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-27
• Last Update Posted: 9 September 2024
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br>