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Clinical Trials/NCT02883907
NCT02883907
Completed
Not Applicable

Advanced MR Imaging of Osteoarthritis

Cambridge University Hospitals NHS Foundation Trust1 site in 1 country20 target enrollmentApril 27, 2017
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Enrollment
20
Locations
1
Primary Endpoint
Mean cartilage T1 relaxation time post gadolinium (milliseconds)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 27, 2017
End Date
November 1, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jamie MacKay

Clinical Research Fellow

Cambridge University Hospitals NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

  • Meets American College of Rheumatology (ACR) criteria for OA
  • Kellgren-Lawrence grade 2-3 OA on knee radiograph
  • Medial compartment predominant disease
  • Neutral alignment
  • Aged 40-60
  • Body Mass Index (BMI) \< 35 kg per square meter
  • Ambulatory and in good general health
  • Group 2 Inclusion Criteria:
  • No current symptoms of knee pain or stiffness or other clinical features of OA
  • Aged 40-60

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Mean cartilage T1 relaxation time post gadolinium (milliseconds)

Time Frame: 1 year

Derived from delayed gadolinium enhanced MR of cartilage (dGEMRIC)

Mean cartilage T1rho relaxation time (milliseconds)

Time Frame: 1 year

Mean cartilage T2 relaxation time (milliseconds)

Time Frame: 1 year

Secondary Outcomes

  • Cartilage thickness values (millimeters)(1 year)
  • Modified Osteoarthritis Knee Score (MOAKS) (arbitrary units)(1 year)
  • Dynamic contrast enhanced (DCE) quantitation of parameters(1 year)
  • Subchondral bone texture index (arbitrary units)(1 year)
  • Subchondral bone area (millimeters squared)(1 year)
  • Osteochondral junction integrity (semiquantitative grading, arbitrary units)(1 year)

Study Sites (1)

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