NCT06591481Completed
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)
Retrospective Case-control Study for the Development of an Artificial Intelligence (AI)-Based Tool of Lesion Detection Based on Magnetic Resonance Imaging (MRI) and Clinical Variables for Early Diagnosis of Axial Spondyloarthritis (axSpA)
Source: ClinicalTrials.gov · Last updated 16 Apr 2025
Brief summary (registry, in English)
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 Magnetic Resonance Imaging (MRI). This study will gather MRI scans from axSpA patients and a control group of participants.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 925 (actual)
- First submitted
- 8 Sept 2024
- Start date
- 19 Feb 2023
- Primary completion date
- 3 Apr 2025
- Lead sponsor
- Ángel Alberich Bayarri
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT06591481
What you commit to
- Study type: Observational
- Participants enrolled: 925
- From 19 Feb 2023 to the primary completion date, 3 Apr 2025
- 7 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Another known pathology in the SIJ which may influence the MRI interpretation.
- Unreadable MRI images or with insufficient diagnostic quality.
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to 44 years · Sex: All · Accepts healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yas Clinic Coordinator of this site? Confirm its status | Abu Dhabi | United Arab Emirates | Unknown status |
| Cleveland Clinic Abu Dhabi Coordinator of this site? Confirm its status | Abu Dhabi | United Arab Emirates | Unknown status |
| Tawam hospital (SEHA) Coordinator of this site? Confirm its status | Al Ain City | United Arab Emirates | Unknown status |
| Emirates Health Services (EHS) Coordinator of this site? Confirm its status | Dubai | United Arab Emirates | Unknown status |
| General University Hospital of Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Royal Medical Services Coordinator of this site? Confirm its status | Amman | Jordan | Unknown status |
| King Saud Medical City Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.