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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02888938
Acronym
Passerelle
Enrollment
173
Registered
2016-09-05
Start date
2015-01-31
Completion date
2017-07-31
Last updated
2016-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Structural Sacro-iliitis

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.

Interventions

OTHERpelvic radiography
OTHERpelvic CT-scan

Sponsors

Pfizer
CollaboratorINDUSTRY
Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with suspected spondyloarthritis

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic value of pelvic radiograph compared to CT-scan of sacro-iliac joint for the diagnosis of structural sacroiliitisbaselineaccording 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 sacroiliitisbaselineaccording 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-scanbaseline
Quantitative assessment of structural lesions of sacro-iliac joints on MRI according to SPARCCbaseline

Countries

France

Contacts

Primary ContactDamien Loeuille, Pr
d.loeuille@chru-nancy.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026