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

NCT03345355 | Terminated

• 1 other identifier: LOCAL/2016/AL-01
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 2

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

Conditions

Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of T1 Dixon post-Gadolinium and T2 Dixon for active sacroiliitis, according to subchondral edema status

  compared to ASAS criteria incorporating Short tau inversion recovery and clinic-biological elements

  Time 0

Secondary Outcomes (4)

• Diagnosis of enthesitis from T1 Gadolinium Dixon sequence vs ASAS criteria

  Time 0

• Diagnosis of synovitis from T2 Dixon and T1 Gadolinium Dixon sequences vs ASAS criteria

  Time 0

• Diagnosis of chronic sacroiliite (erosion or chondral scler osis, or fatty spinal replacement) by T1 Dixon pre-Gadolinium

  Time 0

• Diagnosis of chronic sacroiliite (erosion or chondral sclerosis, or fatty spinal replacement) by conventional sequences

  Time 0

Study Arms (1)

patient with axial spondyloarthritis

Diagnostic Test: Imaging

Interventions

Imaging DIAGNOSTIC_TEST

Coronal oblique T1, Coronal oblique and axial STIR, Coronal oblique T1 Dixon, Coronal oblique and Axial T2 Dixon and T1 Dixon post Gadolinium

patient with axial spondyloarthritis

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

Patients with clinically-confirmed axial spondyloarthritis treated in the radiology services of the CHUs of Montpellier and Nimes

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU Lapeyronie

Montpellier, 34090, France

Location

CHU Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Spondylarthritis

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 17, 2017
• Study Start: November 13, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

FR (2)