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Clinical Trials/NCT03345355
NCT03345355TerminatedNot Applicable

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

Centre Hospitalier Universitaire de Nīmes2 sites in 1 country5 target enrollmentStarted: November 13, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
5
Locations
2
Primary Endpoint
Diagnostic performance of T1 Dixon post-Gadolinium and T2 Dixon for active sacroiliitis, according to subchondral edema status
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Time Frame: Time 0

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

Secondary Outcomes

  • 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)

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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