Status:
COMPLETED
Retrospective Case-Control Study for Developing an Artificial Intelligence (AI) Tool for Lesion Detection Using Magnetic Resonance Imaging (MRI) and Clinical Variables for Early Diagnosis of Axial Spondyloarthritis (axSpA)
Lead Sponsor:
Ángel Alberich Bayarri
Conditions:
Axial Spondyloarthritis (AxSpA)
Eligibility:
All Genders
18-44 years
Brief Summary
The goal of this observational study is to develop and validate an Artificial Intelligence (AI) tool that allows the lesion detection and early diagnosis of axial spondyloarthritis (axSpA) based on Ma...
Detailed Description
BACKGROUND The spondyloarthritis (SpA) are a group of chronic inflammatory diseases of autoimmune nature that share common clinical and genetic features, including an association with HLA-B27 antigen...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Active axSpA patients group:
- Fulfillment of the ASAS criteria for axSpA (i.e. MRI and/or clinical arm, Rudwaleit M, et al., Ann Rheum Dis. 2009 Oct;68(10):1520-7).
- axSpA diagnosis according to the physician.
- Fulfillment of the following MRI criteria (a-c must be fulfilled):
- a) Availability of MRI images of the sacroiliac joint (SIJ) including T1- weighted and STIR and/or T2 Fat-Sat (FS) sequences in coronal-oblique planes.
- b) Fulfillment of ASAS criteria for positive MRI:
- b.1)Bone marrow oedema (BMO) on a T2-weighted sequence sensitive for free water (such as short tau inversion recovery \[STIR\] or T2FS) or bone marrow contrast enhancement on a T1-weighted sequence (such as T1FS post-gadolinium).
- b.2) Inflammation must be clearly present and located in a typical anatomical area (subchondral bone).
- b.3) MRI appearance must be highly suggestive of SpA.
- b.4) Other findings can be present but are not required for a positive MRI (erosion and/or fat metaplasia and/or ankylosis).
- b.5) Fulfillment of ASAS criteria for positive MRI.
- c) MRI expert opinion of having axial SpA.
- Inclusion Criteria for Control group:
- Buttock and/or low back pain due to known trauma, stress, disc herniation with an MRI of SIJ showing absence of bone marrow edema, fatty infiltration and bone erosions and not fulfilling ASAS axSpA classification criteria.
- Availability of MRI images of SIJ including T1-weighted and STIR and/or T2 Fat-Sat sequences in coronal-oblique planes.
- Exclusion Criteria:
- Another known pathology in the SIJ which may influence the MRI interpretation.
- Unreadable MRI images or with insufficient diagnostic quality.
Exclusion
Key Trial Info
Start Date :
February 19 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 3 2025
Estimated Enrollment :
925 Patients enrolled
Trial Details
Trial ID
NCT06591481
Start Date
February 19 2023
End Date
April 3 2025
Last Update
April 16 2025
Active Locations (7)
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1
Royal Medical Services
Amman, Jordan
2
King Saud Medical City
Riyadh, Saudi Arabia, 12746
3
General University Hospital of Valencia
Valencia, Valencia, Spain, 46014
4
Tawam hospital (SEHA)
Al Ain City, Al Maqam, United Arab Emirates