Diagnosis of Structural Sacroiliitis in Patients With Suspicion of Spondyloarthritis (EchoSPA)

Structural Sacro-iliitis Clinical Trial

— Passerelle  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02888938
• Other study ID #: 2014/PasserelleEchoSPA-Loeuill
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2016
• Last updated: August 31, 2016
• Start date: January 2015
• Est. completion date: July 2017

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: Damien Loeuille, Pr
• Email: d.loeuille[@]chru-nancy.fr
• Is FDA regulated: No
• Health authority: France: Ethics Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 173
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with suspected spondyloarthritis

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Sacroiliitis
• Spondylarthritis
• Structural Sacro-iliitis

Intervention

Other:
• pelvic radiography

• pelvic MRI

• pelvic CT-scan

Locations

Country	Name	City	State
France	Service deRhumatologie - CHRU Brabois	Vandoeuvre les Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic value of pelvic radiograph compared to CT-scan of sacro-iliac joint for the diagnosis of structural sacroiliitis	according to New York criteria; CT-scan considered as the gold standard	baseline	No
Primary	Diagnostic value of MRI of sacro-iliac joint compared to CT-scan of sacro-iliac joint for the diagnosis of structural sacroiliitis	according to New York criteria; CT-scan considered as the gold standard	baseline	No
Primary	Quantitative assessment of structural lesions of sacro-iliac joints on CT-scan according to SPARCC for structural assessment and adapted for CT-scan		baseline	No
Primary	Quantitative assessment of structural lesions of sacro-iliac joints on MRI according to SPARCC		baseline	No