FERARI
Research type
Research Study
Full title
Functional Exercise Response on osteoArthritis Relaxation Imaging
IRAS ID
242845
Contact name
Fiona J Gilbert
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 26 days
Research summary
Osteoarthritis (OA) is a degenerative joint disease and the most prevalent cause of mobility impairment and disability among the aging population. Early osteoarthritis is characterised by progressive decomposition of the cartilage microstructure as the tissue begins to lose functional capacity. Indications at early stages of OA include decreased organisation of the collagen matrix, loss of proteoglycans and increased hydration. There are no validated methods to image early changes in cartilage microstructure, which are direly needed in early phase clinical development to offset the growing numbers and costs of end-stage disease.
MRI can probe soft-tissue with physical measurements that are not available through other methods. Quantitative MRI measurements possess the ability to characterise tissue and distinguish pathologies and thus are particularly promising for assessing early changes in the cartilage composition.
An exploratory imaging method is proposed that measures the response of MRI biomarkers during rest, during mechanical joint-loading, and after exercise. These exercise-related biomarker changes have been confirmed in preliminary trials at Cambridge and in literature. This study proposes imaging up to 40 subjects to observe these effects in OA patients and in healthy volunteers. This would be the first known study that evaluates the clinical utility of compositional MRI biomarker changes due to exercise in OA subjects.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
18/EE/0359
Date of REC Opinion
4 Feb 2019
REC opinion
Further Information Favourable Opinion