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

NCT ID: NCT03689881

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-04
• Study Completion Date: 2020-12-31

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.

Conditions

Sacroiliitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Tomosynthesis

Tomosynthesis of SI joints

Group Type: EXPERIMENTAL

Tomosynthesis of SI joints

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DMS Apelem

INDUSTRY

Sponsor Role: collaborator

Thales

UNKNOWN

Sponsor Role: collaborator

Digisens

UNKNOWN

Sponsor Role: collaborator

Medecom

UNKNOWN

Sponsor Role: collaborator

BPIfrance

OTHER

Sponsor Role: collaborator

European Regional Development Fund

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Cyteval, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Locations

Imaging department- University hospital

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Catherine Cyteval, MD, PhD

Role: CONTACT

c-cyteval@chu-montpellier.fr

+ 33 4 67 33 81 78

Facility Contacts

Sophie Lefebvre

Role: primary

s-lefebvre@chu-montpellier.fr

+33 4 67 33 86 07

Celine Engrand

Role: backup

c-engrand@chu-montpellier.fr

+33 4 67 33 86 07

Other Identifiers

RECHMPL18_0328

Identifier Type: -

Identifier Source: org_study_id