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

Value of Tomosynthesis for Detection of Sacro-iliitis: a Prospective Comparative Study

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.

Study Overview

• Status: Unknown
• Conditions: Sacroiliitis
• Intervention / Treatment: Device: Tomosynthesis of SI joints

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Imaging department- University hospital
    • Contact: Sophie Lefebvre; Phone Number: +33 4 67 33 86 07; Email: s-lefebvre@chu-montpellier.fr
    • Contact: Celine Engrand; Phone Number: +33 4 67 33 86 07; Email: c-engrand@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tomosynthesis; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiation dose	Radiation dose will be measured for each imaging evaluation and calculated as the effective dose in millisievert (mSv).	1 day of enrollment
inter reader agreement for the evaluation of sacroiliitis at tomosynthesis	Inter reader agreement will be measured at retrospective evaluation.	at the end of patients enrollment

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: European Regional Development Fund; DMS Apelem; BPIfrance; Thales; Digisens; Medecom
• Investigators: Principal Investigator: Catherine Cyteval, MD, PhD, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: September 27, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: CT; tomosynthesis; Xray; Sacroiliitis; SI joint
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Sacroiliitis
• Other Study ID Numbers: RECHMPL18_0328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No