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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
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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).

Condition or disease Intervention/treatment
Structural Sacro-iliitis 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
Estimated Enrollment : 173 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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 ]
  4. Quantitative assessment of structural lesions of sacro-iliac joints on MRI according to SPARCC [ Time Frame: baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
173 patients issues from ECHOSpA cohort with pelvic radiograph, CT-scan and MRI of SIJ.
Criteria

Inclusion Criteria:

  • Patients with suspected spondyloarthritis

Exclusion Criteria:


Information from the National Library of Medicine

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


Contacts
Contact: Damien Loeuille, Pr d.loeuille@chru-nancy.fr

Locations
France
Service deRhumatologie - CHRU Brabois Recruiting
Vandoeuvre les Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
Pfizer
Investigators
Principal Investigator: Damien Loeuille, Pr Service deRhumatologie - CHRU Brabois

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02888938     History of Changes
Other Study ID Numbers: 2014/PasserelleEchoSPA-Loeuill
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Spondylarthritis
Sacroiliitis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases