Clinical trial NCT03689881: Value of Tomosynthesis for the Detection of Sacro-iliitis (TOMOS SI)
Official title: Value of Tomosynthesis for Detection of Sacro-iliitis: a Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sacroiliitis
Keywords: Sacroiliitis
SI joint
tomosynthesis
CT
Xray
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: DMS Apelem
name: Thales
name: Digisens
name: Medecom
name: BPIfrance
name: European Regional Development Fund
First posted: 2018-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 and over referred for suspected sacroiliitis.
* Patients who have entered into their participation agreement by signing the informed consent form.
* Patient affiliated to a social security scheme or beneficiary.

Exclusion Criteria:

* Pregnant or lactating women.
* Vulnerable people according.
* Major people placed under guardianship or curatorship.

Primary outcomes:
measure: Presence of bone erosions and other structural lesions of SI joints
timeFrame: 1 day of enrollment
Secondary outcomes:
measure: radiation dose
timeFrame: 1 day of enrollment
measure: inter reader agreement for the evaluation of sacroiliitis at tomosynthesis
timeFrame: at the end of patients enrollment
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Imaging department- University hospital
Study officials:
affiliation: Montpellier University Hospital
name: Catherine Cyteval, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: