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

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

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).

Study Overview

• Status: Unknown
• Conditions: Structural Sacro-iliitis
• Intervention / Treatment: Other: pelvic radiography; Other: pelvic MRI; Other: pelvic CT-scan

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.

• Study Type: Observational
• Enrollment (Anticipated): 173

Contacts and Locations

Study Locations

• France
  • Vandoeuvre les Nancy, France
    • Recruiting
    • Service deRhumatologie - CHRU Brabois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

173 patients issues from ECHOSpA cohort with pelvic radiograph, CT-scan and MRI of SIJ.

Description

Inclusion Criteria:

• Patients with suspected spondyloarthritis

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients suspected of SpA	Other: pelvic radiography; Other: pelvic MRI; Other: pelvic CT-scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Quantitative assessment of structural lesions of sacro-iliac joints on CT-scan according to SPARCC for structural assessment and adapted for CT-scan		baseline
Quantitative assessment of structural lesions of sacro-iliac joints on MRI according to SPARCC		baseline

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: Pfizer
• Investigators: Principal Investigator: Damien Loeuille, Pr, Service deRhumatologie - CHRU Brabois

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 5, 2016

Study Record Updates

• Last Update Posted (Estimate): September 5, 2016
• Last Update Submitted That Met QC Criteria: August 31, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis; Sacroiliitis
• Other Study ID Numbers: 2014/PasserelleEchoSPA-Loeuill

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No