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

Official title

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

Overview

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

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

Primary outcome measures

• WB-MRI imaging characteristics of patients with axSpA. [Time frame: Two years]

Secondary outcome measures (1)

• The correlation between WB-MRI changes and disease activities [Time frame: Five yeas]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

China · 1 center

• The First Affiliated Hospital of Nanjing Medical University — Nanjing

Publications

• Treitl KM, Ricke J, Baur-Melnyk A. Whole-body magnetic resonance imaging (WBMRI) versus whole-body computed tomography (WBCT) for myeloma imaging and staging. Skeletal Radiol. 2022 Jan;51(1):43-58. doi: 10.1007/s00256-021-03799-4. Epub 2021 May 24. PMID 34031705
• Hynes JP, Hughes N, Cunningham P, Kavanagh EC, Eustace SJ. Whole-body MRI of bone marrow: A review. J Magn Reson Imaging. 2019 Dec;50(6):1687-1701. doi: 10.1002/jmri.26759. Epub 2019 Apr 23. PMID 31016800
• Guo Z, Li B, Zhang Y, Kong C, Liu Y, Qu J, Zhan Y, Shen Z, Lei X. Peripheral enthesitis assessed by whole-body MRI in axial spondyloarthritis: Distribution and diagnostic value. Front Immunol. 2022 Aug 23;13:976800. doi: 10.3389/fimmu.2022.976800. eCollection 2022. PMID 36081521
• Poggenborg RP, Eshed I, Ostergaard M, Sorensen IJ, Moller JM, Madsen OR, Pedersen SJ. Enthesitis in patients with psoriatic arthritis, axial spondyloarthritis and healthy subjects assessed by 'head-to-toe' whole-body MRI and clinical examination. Ann Rheum Dis. 2015 May;74(5):823-9. doi: 10.1136/annrheumdis-2013-204239. Epub 2014 Jan 3. PMID 24389294
• Krabbe S, Ostergaard M, Eshed I, Sorensen IJ, Jensen B, Moller JM, Balding L, Madsen OR, Asmussen K, Eng G, Jorgensen NR, Pedersen SJ. Whole-body Magnetic Resonance Imaging in Axial Spondyloarthritis: Reduction of Sacroiliac, Spinal, and Entheseal Inflammation in a Placebo-controlled Trial of Adalimumab. J Rheumatol. 2018 May;45(5):621-629. doi: 10.3899/jrheum.170408. Epub 2018 Feb 15. PMID 29449506
• Karpitschka M, Godau-Kellner P, Kellner H, Horng A, Theisen D, Glaser C, Brandlhuber B, Reiser M, Weckbach S. Assessment of therapeutic response in ankylosing spondylitis patients undergoing anti-tumour necrosis factor therapy by whole-body magnetic resonance imaging. Eur Radiol. 2013 Jul;23(7):1773-84. doi: 10.1007/s00330-013-2794-1. Epub 2013 Mar 15. PMID 23494493
• Poggenborg RP, Pedersen SJ, Eshed I, Sorensen IJ, Moller JM, Madsen OR, Thomsen HS, Ostergaard M. Head-to-toe whole-body MRI in psoriatic arthritis, axial spondyloarthritis and healthy subjects: first steps towards global inflammation and damage scores of peripheral and axial joints. Rheumatology (Oxford). 2015 Jun;54(6):1039-49. doi: 10.1093/rheumatology/keu439. Epub 2014 Nov 26. PMID 25431482
• Weckbach S. Whole-body MRI for inflammatory arthritis and other multifocal rheumatoid diseases. Semin Musculoskelet Radiol. 2012 Nov;16(5):377-88. doi: 10.1055/s-0032-1329881. Epub 2012 Dec 4. PMID 23212873

Identifiers

NCT: NCT07230327 · SPA-JS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗