Value of Tomosynthesis for the Detection of Sacro-iliitis (TOMOS SI)

NCT03689881 | Unknown

• 1 other identifier: RECHMPL18_0328
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroiliitis

Keywords

Sacroiliitis; SI joint; tomosynthesis; CT; Xray

Outcome Measures

Primary Outcomes (1)

• 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

  1 day of enrollment

Secondary Outcomes (2)

• radiation dose

  1 day of enrollment

• inter reader agreement for the evaluation of sacroiliitis at tomosynthesis

  at the end of patients enrollment

Study Arms (1)

Tomosynthesis

EXPERIMENTAL

Tomosynthesis of SI joints

Device: Tomosynthesis of SI joints

Interventions

Tomosynthesis of SI joints DEVICE

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.

Tomosynthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• DMS Apelem: collaborator
• Thales: collaborator
• Digisens: collaborator
• Medecom: collaborator
• BPIfrance: collaborator
• European Regional Development Fund: collaborator

Study Sites (1)

Imaging department- University hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Sacroiliitis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Catherine Cyteval, MD, PhD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Cyteval, MD, PhD

CONTACT

+ 33 4 67 33 81 78; c-cyteval@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 1, 2018
• Study Start: October 4, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: September 27, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)