Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
NCT Number: NCT02883907
The utility of conventional imaging in the development of new treatments for osteoarthritis (OA) is hindered by:
1. Difficulty in non-invasively evaluating the initial response to potential new treatment options. OA typically develops over a long time period, so evaluating the efficacy of new treatment options over a timeframe relevant to experimental medicine studies is difficult. 2. Inadequate methods of disease quantification and stratification. OA is a heterogeneous condition and identifying which subgroups of patients are most likely to benefit from new treatments is crucial.
Novel magnetic resonance (MR) imaging acquisition and analysis techniques have the potential to solve these problems. However, their reliability needs to be fully established and knowledge of likely effect sizes is required to inform sample size considerations for further longitudinal/interventional studies.
This study aims to help address these issues by:
1. Calculating effect sizes for MR measurements to inform sample size calculations for future studies. 2. Assessing the reliability of a multiparametric MR protocol for assessment of the knee joint.
The investigators will examine a single knee of an initial 15 participants with MR. Participants will be drawn from two groups: (1) 10 participants aged 40-60 years old with clinical and x-ray features of OA and (2) 5 control subjects (matched to cases for age, sex and body mass index in a 1:2 ratio) who do not have clinical features of OA.
Participants will undergo an initial (baseline) MR examination, followed by repeat MR examinations at approximately 1 month and 1 year following the baseline examination.
This will allow us to assess both the reliability of our MR measurements and the expected progression in our MR measurements in OA subjects in the absence of any disease-modifying intervention.
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Notify Me40 year–60 year
All sexes
Observational
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Group 1 Inclusion Criteria:
Group 2 Inclusion Criteria:
Exclusion criteria
(both groups):
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Derived from delayed gadolinium enhanced MR of cartilage (dGEMRIC)
Time frame: 1 year
Semiquantitative scoring system
Time frame: 1 year
Surface-based comparison using statistical parametric mapping
Time frame: 1 year
Time frame: 1 year
Multiple DCE parameters calculated allowing description of enhancement rate and pattern of synovium
Time frame: 1 year
Time frame: 1 year
Cambridge University Hospitals NHS Foundation Trust
Other
Acronym: AMROA
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