MRI of Sacroiliac Joints: Evaluation of Accuracy of Dixon Sequences in the Diagnosis of Axial Spondyloarthritis

Terminated

• Conditions: Spondyloarthritis
• Interventions: Diagnostic Test: Imaging

• Registration Number: NCT03345355
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The investigators hypothesize that the T1 Dixon post-Gadolinium and T2 Dixon sequences will show good diagnostic performances for active sacroiliitis compared to the reference test (Short tau inversion recovery) and clinical-biological criteria, which will allow a better diagnosis of active sacroiliitis

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-17
• Study Start: 2018-11-13
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• The patient is at least 18 years old
• The patient has a clinically diagnosed axial spondyloarthritis (axSpA) (ASAS or AMOR classification)
• Patient has an active axSpA (BASDAI>4)

Exclusion Criteria

• The subject is participating in another study, or is in a period of exclusion determined by a previous study
• The subject refuses to sign the consent
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• The patient is pregnant or breastfeeding
• The patient has a contra-indication

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient with axial spondyloarthritis	Imaging	-

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of T1 Dixon post-Gadolinium and T2 Dixon for active sacroiliitis, according to subchondral edema status	Time 0	compared to ASAS criteria incorporating Short tau inversion recovery and clinic-biological elements

Secondary Outcome Measures

Name	Time	Method
Diagnosis of enthesitis from T1 Gadolinium Dixon sequence vs ASAS criteria	Time 0	Yes/no
Diagnosis of synovitis from T2 Dixon and T1 Gadolinium Dixon sequences vs ASAS criteria	Time 0	Yes/no
Diagnosis of chronic sacroiliite (erosion or chondral scler osis, or fatty spinal replacement) by T1 Dixon pre-Gadolinium	Time 0	Yes/No
Diagnosis of chronic sacroiliite (erosion or chondral sclerosis, or fatty spinal replacement) by conventional sequences	Time 0	Yes/no

Trial Locations

Locations (2)

CHU Lapeyronie; 🇫🇷 Montpellier, France

CHU Nimes; 🇫🇷 Nîmes, France