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

Spondyloarthritis Clinical Trial

— SPADIX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03345355
• Other study ID #: LOCAL/2016/AL-01
• Status: Terminated
• Start date: November 13, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spondylarthritis
• Spondyloarthritis

Intervention

Diagnostic Test:
• Imaging
Coronal oblique T1, Coronal oblique and axial STIR, Coronal oblique T1 Dixon, Coronal oblique and Axial T2 Dixon and T1 Dixon post Gadolinium

Locations

Country	Name	City	State
France	CHU Lapeyronie	Montpellier
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diagnosis of enthesitis from T1 Gadolinium Dixon sequence vs ASAS criteria	Yes/no	Time 0
Secondary	Diagnosis of synovitis from T2 Dixon and T1 Gadolinium Dixon sequences vs ASAS criteria	Yes/no	Time 0
Secondary	Diagnosis of chronic sacroiliite (erosion or chondral scler osis, or fatty spinal replacement) by T1 Dixon pre-Gadolinium	Yes/No	Time 0
Secondary	Diagnosis of chronic sacroiliite (erosion or chondral sclerosis, or fatty spinal replacement) by conventional sequences	Yes/no	Time 0