Juvenile Arthritis Quantitative Imaging

NCT02684695 | Unknown

• 1 other identifier: JAQI
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to develop and validate quantitative magnetic resonance imaging biomarkers as measures of disease activity in juvenile idiopathic arthritis (JIA). This includes patients with enthesitis-related arthritis (ERA).

Conditions

Arthritis, Juvenile Idiopathic; Enthesitis-Related Arthritis, Juvenile

Keywords

Magnetic resonance imaging; Imaging biomarker; Diffusion-weighted imaging

Outcome Measures

Primary Outcomes (1)

• Percentage agreement between novel biomarker measurements (apparent diffusion coefficient and fat fraction) and existing scores of inflammation (SPARCC STIR score)

  NB: Agreement is a single statistical parameter which is derived by comparison of two measurements - it is this parameter (rather than the measurements) which is the outcome measure.

  5 years

Secondary Outcomes (1)

• Scoring systems for whole body imaging, and novel approaches to measuring bone marrow disease

  5 years

Study Arms (2)

Group A

Patients with enthesitis-related arthritis

Other: MRI scan (adolescent spine protocol)

Group B

Patients with other forms of juvenile idiopathic arthritis (extended oligoarticular JIA and polyarticular JIA)

Other: MRI scan (whole body protocol)

Interventions

MRI scan (adolescent spine protocol) OTHER

MRI scan of the lumbar spine and sacroiliac joints

Group A

MRI scan (whole body protocol) OTHER

MRI scan of multiple joints ('whole body')

Group B

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants with JIA will have a definitive clinical diagnosis of JIA according to established clinical criteria.9 Patients will be divided according to subtype - patients with ERA will be recruited into groups A (DWI and FF) and / or Group B (WB MRI) along with the polyarthritis and extended oligoarthritis groups. Once the WB MRI protocol is defined, for ERA patients recruited to both arms of the study the intention is to combine the DWI and WB MRI scan together to limit participation to 6 months scans only for this group. Additionally, patients who are being investigated for possible JIA/ERA will be asked to participate in this study. Those patients who are subsequently diagnosed with JIA/ERA will be included in the study as described above. Those patients who are diagnosed with mechanical back pain will be treated as controls, and will not be imaged again after this point.

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• For cases, patients will have clinical diagnosis of JIA: enthesitis-related arthropathy, extended oligoarthritis or polyarthritis (defined according to ILAR criteria)
• For controls, patients will have a diagnosis of mechanical back pain (though to arise from muscles, bones, ligaments or discs), with normal inflammatory markers
• Age 12-24

You may not qualify if:

• Contra-indication to MRI scan (e.g. metal foreign object)
• Unable to give consent
• Unable to speak English
• Unable to tolerate an MRI scan (e.g. due to claustrophobia, contrast allergy)
• Renal or hepatic failure (eGFR \< 30ml/min for renal failure, where applicable)

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (1)

University College London Centre for Medical Imaging

London, NW12PG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Timothy JP Bray, MBBChir

CONTACT

0203 447 9324; t.bray@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiology SpR and PhD student

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 18, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2026
• Last Updated: May 2, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)