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Whole Body MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Radiographic axSpA and Non-radiographic axSpA

Research on a New Disease Activity Assessment System for axSpA Based on Whole-body Magnetic Resonance Imaging Cohort

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07230327
Acronym
NJSpAM
Enrollment
100
Registered
2025-11-17
Start date
2022-01-01
Completion date
2026-12-31
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondyloarthritis (SpA), Whole-body MRI (WBMRI)

Brief summary

This study aims to further improve and expand the WB-MRI imaging evaluation cohort of axSpA patients to complete dynamic follow-up and condition assessment. Based on the WB-MRI features, the association of WB-MRI signs with disease activity, inflammation, and structural damage will be analyzed. At the same time, in-depth data mining was conducted and machine learning was used to construct a new axSpA disease activity assessment model based on WB-MRI data, and the accuracy and reliability of the model were clearly evaluated in the discovery cohort and validation cohort.

Detailed description

Axial spondyloarthritis (axSpA) is a common clinical chronic inflammatory joint disease with a high disability rate. Current assessment of axSpA disease activity mainly relies on patients' self-reported symptoms and signs, which has poor accuracy and reliability. At the same time, existing assessment methods fail to include some important disease characteristics of axSpA, such as active spinal inflammation and enthesitis. Therefore, there is an urgent need to establish a new axSpA disease activity assessment system. With the development of imaging technology, whole-body MRI (WB-MRI) scanning technology is highly sensitive, can detect multiple parts at the same time, and can fuse multiple sequence images to make disease location and diagnosis more accurate. Currently, Much attention has been paid to it, but it has been less studied in axSpA. This study established a disease activity assessment model based on WB-MRI imaging assessment, which will provide a new, effective and accurate method for axSpA disease assessment. At the same time, it will provide theoretical basis and practical basis for further understanding of the clinical characteristics of axSpA, the relationship between inflammation and structural damage.

Interventions

These studies will be performed on a 3Tesla (T) MR system (Achieva, Philips Medical Systems) for all patients.

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
WB-MRI imaging characteristics of patients with axSpA.Two yearsCompare the correlation between WB-MRI changes and disease activity, disease progression and structural damage at baseline and after 2 years of follow-up.

Secondary

MeasureTime frameDescription
The correlation between WB-MRI changes and disease activitiesFive yeasTo elucidate the correlation between WB-MRI changes and inflammation, structural damage and disease activity in patients with axSpA.

Countries

China

Contacts

Primary ContactWenfeng Tan, Dr
tw2006@njmu.edu.cn+8618061202878

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026