Clinimetric properties of Oxygen-Enhanced MRI
Research type
Research Study
Full title
Determining the clinimetric properties of structural and functional outputs of oxygen-enhanced magnetic resonance imaging in children and adults with cystic fibrosis (CF) and chronic suppurative lung disease (CSLD)
IRAS ID
294686
Contact name
Jane C Davies
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
Scope: Monitoring people with cystic fibrosis (pwCF) and chronic suppurative lung disease (CSLD) is hampered by the relative insensitivity of current outcome measures (eg. spirometry) to detect subtle changes or an inability to perform frequently (eg. related to the radiation burden of CT scanning).
OE-MRI is a sensitive test with the potential to provide both regional and global lung structural, plus functional scores, without radiation. In this study, we intend to build on our promising pilot data and establish clinimetric applications of OE-MRI.
Design: Cross-sectional, cohort, and longitudinal observational study.
Hypothesis: Functional and structural outputs from OE-MRI lung are feasible and valid outcome measures in people with cystic fibrosis
Aims
To determine the clinimetric properties of structural and functional outputs of OE-MRI in children and adults with CF and CSLD, specifically:
1. How stable are repeated tests; do the values change over short periods of time (2-4 weeks)?
2. How do the values change over longer periods of time, when disease might be progressing (6 months – 2 years)?
3. How does OE-MRI compare to other lung function tests?
4. How well do changes in OE-MRI reflect periods of ill-health (exacerbations) and recovery?
5. Intra and inter-rater agreement on structural MRI scores
Study Outcomes
Primary outcome: Variability of OE-MRI (OE outputs and structural scores) in healthy controls (HCs; short term) and clinically stable pwCF (short and longer term)
Secondary outcomes:
• Relationships between structural and functional components of OE-MRI
• Relationships between both the above and other measures of lung function, spirometry and MBW
• Change in OE-MRI outputs during periods of pulmonary exacerbation
• Intra and inter-rater agreement for structural MRI scores
Exploratory outcomes:
• Impact on the above of baseline clinical features including sex, treatment with highly-effective CFTR modulator therapy (HEMT), infection status, age, nutritional parameters.Study duration: 4 years (to allow long term follow-up of patients).
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
21/PR/0807
Date of REC Opinion
16 Sep 2021
REC opinion
Further Information Favourable Opinion