Structural Sacro-iliitisPasserelleNCT02888938
Diagnosis of Structural Sacroiliitis in Patients With Suspicion of Spondyloarthritis (EchoSPA)
An observational study of Structural Sacro-iliitis, run by Central Hospital, Nancy, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Structural Sacro-iliitis
- What is being tested?
- pelvic radiography, pelvic MRI and pelvic CT-scan
- How many people
- 173 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 173 patients issues from ECHOSpA cohort with pelvic radiograph, CT-scan and MRI of SIJ.
Who may be able to join
- Patients with suspected spondyloarthritis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Damien Loeuille, Pr contact
France1 site, 1 recruiting
- Recruiting
Service deRhumatologie - CHRU Brabois
Vandœuvre-lès-Nancy
About this study
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
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).
Read the 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.
- Conditions
- Structural Sacro-iliitis
- Being tested
- pelvic radiography, pelvic MRI, pelvic CT-scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic radiographyOther
pelvic MRIOther
pelvic CT-scanOther
| Study group | Role | What they receive |
|---|---|---|
| Patients suspected of SpA | Not described Receives: Other: pelvic radiography; Other: pelvic MRI; Other: pelvic CT-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline
Quantitative assessment of structural lesions of sacro-iliac joints on CT-scan according to SPARCC for structural assessment and adapted for CT-scan
Measured: baseline
Quantitative assessment of structural lesions of sacro-iliac joints on MRI according to SPARCC
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Structural Sacro-iliitisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 173 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Damien Loeuille, Pr, Principal investigator, Service deRhumatologie - CHRU Brabois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888938
- Sponsor's protocol ID
- 2014/PasserelleEchoSPA-Loeuill
- Acronym
- Passerelle
- Status last verified
- Aug 2016
- First submitted
- 31 Aug 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02888938
- Acronym / sponsor ID
- Passerelle / 2014/PasserelleEchoSPA-Loeuill
- Conditions
- Structural Sacro-iliitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 173 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suspected of SpA | – | Other: pelvic radiography, Other: pelvic MRI, Other: pelvic CT-scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 173 patients issues from ECHOSpA cohort with pelvic radiograph, CT-scan and MRI of SIJ.
Key inclusion criteria (1 listed)
- Patients with suspected spondyloarthritis
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pelvic radiography | Other | Patients suspected of SpA |
| pelvic MRI | Other | Patients suspected of SpA |
| pelvic CT-scan | Other | Patients suspected of SpA |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damien Loeuille, Pr contact
Damien Loeuille, Pr principal investigator
Service deRhumatologie - CHRU Brabois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Structural Sacro-iliitis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damien Loeuille, Pr (d.loeuille@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value of pelvic radiograph compared to CT-scan of sacro-iliac joint for the diagnosis of structural sacroiliitis (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.