Whole-body MRI for non-invasive lesion detection and therapy follow-up in radiographic and non-radiographic axial spondyloarthritis
Research on a New Disease Activity Assessment System for axSpA Based on Whole-body Magnetic Resonance Imaging Cohort
This project will try whole-body MRI to find lesions and track treatment response in people with radiographic or non-radiographic axial spondyloarthritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07230327 on ClinicalTrials.gov |
What this trial studies
This is an observational cohort using whole-body MRI (WB-MRI) to image multiple body regions in patients with suspected axial spondyloarthritis and to follow them over time. Imaging features from WB-MRI will be correlated with clinical measures of disease activity, inflammation, and structural damage. The project will apply data mining and machine-learning methods to build a WB-MRI–based disease activity model, with separate discovery and validation cohorts to test accuracy and reliability. Dynamic follow-up imaging will be used to examine how MRI findings change with therapy and clinical course.
Who should consider this trial
Good fit: Newly referred people with symptom onset before age 45 who have chronic back pain (>3 months) and/or peripheral arthritis, enthesitis, or dactylitis and who are not already diagnosed with axial SpA are the intended participants.
Not a fit: People already diagnosed with radiographic or non-radiographic axial SpA, those with symptom onset after age 45, or individuals with contraindications to MRI (for example certain implanted devices or severe claustrophobia) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the project could provide a more objective, imaging-based way to measure disease activity and monitor treatment response in axial spondyloarthritis.
How similar studies have performed: Whole-body MRI has shown promise in small axSpA cohorts for detecting inflammation, but using WB-MRI combined with machine-learning to create a validated disease-activity model is relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Include newly referred patients if: The onset of symptoms (back pain/arthritis/enthesitis) \< 45 years Undiagnosed disease with the following symptoms: chronic back pain (duration of back pain more than 3 months) and/or peripheral arthritis (asymmetric arthritis/predominantly of the lower limbs) and/or enthesitis and/or dactylitis Exclusion Criteria: And diagnosed with non-radiographic or radiographic axial SpA
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Wenfeng Tan, Dr
- Email: tw2006@njmu.edu.cn
- Phone: +8618061202878
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.