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

NCT07230327 | Recruiting DMC FDA Drug FDA Device

• 1 other identifier: SPA-JS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• WB-MRI imaging characteristics of patients with axSpA.

  Compare the correlation between WB-MRI changes and disease activity, disease progression and structural damage at baseline and after 2 years of follow-up.

  Two years

Secondary Outcomes (1)

• The correlation between WB-MRI changes and disease activities

  Five yeas

Interventions

Whole body MRI PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Exclusion Criteria: Unable to provide written consent Unable to undergo MRI examination Pregnancy Unable to read and/or write Chinese

You may qualify if:

• 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

You may not qualify if:

• And diagnosed with non-radiographic or radiographic axial SpA

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Althoff CE, Sieper J, Song IH, Haibel H, Weiss A, Diekhoff T, Rudwaleit M, Freundlich B, Hamm B, Hermann KG. Active inflammation and structural change in early active axial spondyloarthritis as detected by whole-body MRI. Ann Rheum Dis. 2013 Jun;72(6):967-73. doi: 10.1136/annrheumdis-2012-201545. Epub 2012 Jun 26.

  PMID: 22736088 BACKGROUND

• Krabbe S, Eshed I, Sorensen IJ, Jensen B, Moller JM, Balding L, Madsen OR, Pedersen SJ, Ostergaard M. Whole-body Magnetic Resonance Imaging Inflammation in Peripheral Joints and Entheses in Axial Spondyloarthritis: Distribution and Changes during Adalimumab Treatment. J Rheumatol. 2020 Jan;47(1):50-58. doi: 10.3899/jrheum.181159. Epub 2019 Apr 1.

  PMID: 30936290 BACKGROUND

• Weiss BG, Bachmann LM, Pfirrmann CW, Kissling RO, Zubler V. Whole Body Magnetic Resonance Imaging Features in Diffuse Idiopathic Skeletal Hyperostosis in Conjunction with Clinical Variables to Whole Body MRI and Clinical Variables in Ankylosing Spondylitis. J Rheumatol. 2016 Feb;43(2):335-42. doi: 10.3899/jrheum.150162. Epub 2015 Dec 15.

  PMID: 26669910 BACKGROUND

• Althoff CE, Sieper J, Song IH, Weiss A, Diekhoff T, Haibel H, Hamm B, Hermann KG. Comparison of Clinical Examination versus Whole-body Magnetic Resonance Imaging of Enthesitis in Patients with Early Axial Spondyloarthritis during 3 Years of Continuous Etanercept Treatment. J Rheumatol. 2016 Mar;43(3):618-24. doi: 10.3899/jrheum.150659. Epub 2016 Feb 1.

  PMID: 26834218 BACKGROUND

MeSH Terms

Conditions

Spondylarthritis

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Central Study Contacts

Wenfeng Tan, Dr

CONTACT

+8618061202878; tw2006@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: November 17, 2025
• Study Start: January 1, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)