Clinical trial NCT02888938: Diagnosis of Structural Sacroiliitis in Patients With Suspicion of Spondyloarthritis (EchoSPA)
Official title: Performance of Pelvic Radiograph, CT -Scan and MRI of the Sacroiliac Joints to Diagnose Structural Sacroiliitis in a Large Cohort of Patients With Suspicion of Spondyloarthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Structural Sacro-iliitis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2016-09-05
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 173 patients issues from ECHOSpA cohort with pelvic radiograph, CT-scan and MRI of SIJ.

Brief summary: The aims of this study are: 1° to assess the value of pelvic radiography and sacro-iliac joint (SIJ) MRI compared to CT scan of SIJ for the diagnosis of structural sacro-iliitis and 2° to quantify structural elementary lesions on MRI and for the first time on CT-scan according to a SPARCC approach in a cohort of patients with a suspicion of spondyloarthritis (ECHOSpA).

Detailed description: Among the 489 patients of the cohort, MRI and CT examination of SIJ were performed simultaneously with pelvic radiographs in 173 patients. After harmonization, readers will be tested for inter-reader reproducibility for modified New York criteria, and scoring of each structural elementary lesion depicted on MRI (erosions, fat metaplasia, backfill, sclerosis and ankylosis) and on CT-scan (erosion, joint space narrowing, sclerosis and ankylosis). When acceptable inter-reader reproducibility will be obtained, exams will be blindly and independently scored by 2 readers (rheumatologist and/or radiologist) in the following order: 1/ pelvic radiographs, 2/ MRI, 3/ CT-scan. In case of discordance between readers for the diagnosis of sacroiliitis, an adjudicator will define the final diagnosis for each imaging method (senior rheumatologist or radiologist). Severity of each structural lesion will be scored quantitatively according to structural SPARCC approach. Only lesions observed in the synovial part of the SIJ on 2 successive slices will be taken into account.

Sensibility, specificity and concordance for the diagnosis of structural sacroiliitis for radiograph and MRI will be calculated with the CT-scan considered as the gold standard. Quantitative MRI and CT scores will be compared for each lesion: erosion, sclerosis and ankylosis. This quantitative approach will be used to explain cases of discordance or concordance for radiograph and MRI.

Eligibility criteria: Inclusion Criteria:

* Patients with suspected spondyloarthritis

Exclusion Criteria:

-

Primary outcomes:
measure: Diagnostic value of pelvic radiograph compared to CT-scan of sacro-iliac joint for the diagnosis of structural sacroiliitis
timeFrame: baseline
measure: Diagnostic value of MRI of sacro-iliac joint compared to CT-scan of sacro-iliac joint for the diagnosis of structural sacroiliitis
timeFrame: baseline
measure: Quantitative assessment of structural lesions of sacro-iliac joints on CT-scan according to SPARCC for structural assessment and adapted for CT-scan
timeFrame: baseline
measure: Quantitative assessment of structural lesions of sacro-iliac joints on MRI according to SPARCC
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: Service deRhumatologie - CHRU Brabois
Study officials:
affiliation: Service deRhumatologie - CHRU Brabois
name: Damien Loeuille, Pr
role: PRINCIPAL_INVESTIGATOR
References: