Value of Tomosynthesis for the Detection of Sacro-iliitis (TOMOS SI) (TOMOS SI)
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|ClinicalTrials.gov Identifier: NCT03689881|
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : September 27, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Sacroiliitis||Device: Tomosynthesis of SI joints||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Value of Tomosynthesis for Detection of Sacro-iliitis: a Prospective Comparative Study|
|Actual Study Start Date :||October 4, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
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 [ Time Frame: 1 day of enrollment ]sacroiliitis will be assessed independently for each imaging modality according to the modified New York criteria
- radiation dose [ Time Frame: 1 day of enrollment ]Radiation dose will be measured for each imaging evaluation and calculated as the effective dose in millisievert (mSv).
- inter reader agreement for the evaluation of sacroiliitis at tomosynthesis [ Time Frame: at the end of patients enrollment ]Inter reader agreement will be measured at retrospective evaluation.
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): NCT03689881
|Contact: Catherine Cyteval, MD, PhD||+ 33 4 67 33 81 firstname.lastname@example.org|
|Principal Investigator:||Catherine Cyteval, MD, PhD||Montpellier University Hospital|