Diagnosis of Structural Sacroiliitis in Patients With Suspicion of Spondyloarthritis (EchoSPA) (Passerelle)
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|ClinicalTrials.gov Identifier: NCT02888938|
Recruitment Status : Unknown
Verified August 2016 by Central Hospital, Nancy, France.
Recruitment status was: Recruiting
First Posted : September 5, 2016
Last Update Posted : September 5, 2016
|Condition or disease||Intervention/treatment|
|Structural Sacro-iliitis||Other: pelvic radiography Other: pelvic MRI Other: pelvic CT-scan|
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.
|Study Type :||Observational|
|Estimated Enrollment :||173 participants|
|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 Start Date :||January 2015|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2017|
|Patients suspected of SpA||
Other: pelvic radiography
Other: pelvic MRI
Other: pelvic CT-scan
- Diagnostic value of pelvic radiograph compared to CT-scan of sacro-iliac joint for the diagnosis of structural sacroiliitis [ Time Frame: baseline ]according to New York criteria; CT-scan considered as the gold standard
- Diagnostic value of MRI of sacro-iliac joint compared to CT-scan of sacro-iliac joint for the diagnosis of structural sacroiliitis [ Time Frame: baseline ]according to New York criteria; CT-scan considered as the gold standard
- Quantitative assessment of structural lesions of sacro-iliac joints on CT-scan according to SPARCC for structural assessment and adapted for CT-scan [ Time Frame: baseline ]
- Quantitative assessment of structural lesions of sacro-iliac joints on MRI according to SPARCC [ Time Frame: baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888938
|Contact: Damien Loeuille, Prfirstname.lastname@example.org|
|Service deRhumatologie - CHRU Brabois||Recruiting|
|Vandoeuvre les Nancy, France|
|Principal Investigator:||Damien Loeuille, Pr||Service deRhumatologie - CHRU Brabois|