Advanced MR Imaging of Osteoarthritis

Osteoarthritis Clinical Trial

— AMROA  

Official title:

Advanced MR Imaging of Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883907
• Other study ID #: 609/M/C/1670
• Status: Completed
• Start date: April 27, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: January 2019
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Group 1 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

• BMI < 35 kg per square meter

• Ambulatory and in good general health

Exclusion Criteria (both groups):

• History of ipsilateral lower limb fracture

• History of ipsilateral lower limb surgery (including arthroscopy)

• Metabolic bone disease

• Inflammatory arthritis

• Haematological malignancy

• Paget's disease

• Bone metastases

• Contraindication to MR imaging (e.g. pacemaker, severe claustrophobia)

• Contraindication to intravenous gadolinium based contrast medium administration (see 'Ethical Considerations' section)

• Unable to consent

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean cartilage T1rho relaxation time (milliseconds)		1 year
Primary	Mean cartilage T2 relaxation time (milliseconds)		1 year
Primary	Mean cartilage T1 relaxation time post gadolinium (milliseconds)	Derived from delayed gadolinium enhanced MR of cartilage (dGEMRIC)	1 year
Secondary	Modified Osteoarthritis Knee Score (MOAKS) (arbitrary units)	Semiquantitative scoring system	1 year
Secondary	Cartilage thickness values (millimeters)	Surface-based comparison using statistical parametric mapping	1 year
Secondary	Subchondral bone area (millimeters squared)		1 year
Secondary	Dynamic contrast enhanced (DCE) quantitation of parameters	Multiple DCE parameters calculated allowing description of enhancement rate and pattern of synovium	1 year
Secondary	Subchondral bone texture index (arbitrary units)		1 year
Secondary	Osteochondral junction integrity (semiquantitative grading, arbitrary units)		1 year