An interventional study of Tomosynthesis of SI joints in Sacroiliitis, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-27.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic
Spondyloarthropathies (SpAs) are chronic inflammatory diseases encompassing ankylosing spondylitis, psoriatic arthritis, reactive arthritis, enteropathic arthropathy, and undifferentiated SpA.
In 2001, the estimated prevalence of SpA was 1.5% worldwide. Sacroiliitis is a condition caused by inflammation within the sacroiliac joint. It is the most frequent damage of SpA depicted at imaging evaluation.
Conventional radiography (X-ray) is usually used to depict the structural changes associated with sacroiliitis.
However further evaluation often requires additionnal computed tomography (CT).
Tomosynthesis is an Xray-based imaging technology which allows reconstruction of multiple section images from a set of projection images acquired as the x-ray tube moves along a prescribed path. The advantagee of tomosynthesis is the significant reduction of radiation dose exposure compared to CT Tomosynthesis is currently used in the field of breast imaging and pneumology. Very few studies have examined the value of tomosynthesis for osteoarticular imaging.
The study aims at evaluating the diagnostic performances of tomosynthesis as compared to standard X-ray and CT, in patients with a clinical suspicion of sacroiliitis.
the investigators hypothesize that tomosynthesis is superior to conventional radiography for detection of sacroiliitis and is at least equal to CT with lower irradiation.
Consecutive patients referred to CT for exploration of sacrollitis will be included and investigated with standard radiography, CT and tomosynthesis of SI joints.
Imaging examinations will be performed at day of enrollment as follow : X-ray and CT as standard management and tomosynthesis as additional evaluation. CT will be considered as the reference standard Sacroiliitis will be assessed in a centralized, blind and randomized retrospective reading of all imaging modalities by two independent radiologists.
Diagnostic performances and radiation doses of tomosynthesis will be compared to those of standard CT and X-ray examinations.
42 studies on the registry are indexed under Sacroiliitis; 11 are open to participants now.
This study's planned enrollment of 30 is below the median of 48 across 28 interventional studies indexed under Sacroiliitis.
Browse Sacroiliitis studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tomosynthesis of SI joints
Device: Tomosynthesis of SI joints
All patients will undergo additional tomosynthesis performed per study protocol along with Xray and CT performed as part of standard imaging evaluation of sacroillitis. Tomosynthesis of SI joints will be performed on a digital Tomosynthesis system (PLATINUM dRF v2 DMS/APELEM), with a single acquisition followed by coronal image reconstruction.
Presence of bone erosions and other structural lesions of SI joints
sacroiliitis will be assessed independently for each imaging modality according to the modified New York criteria
Time frame: 1 day of enrollment
radiation dose
Radiation dose will be measured for each imaging evaluation and calculated as the effective dose in millisievert (mSv).
Time frame: 1 day of enrollment
inter reader agreement for the evaluation of sacroiliitis at tomosynthesis
Inter reader agreement will be measured at retrospective evaluation.
Time frame: at the end of patients enrollment
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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