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

Primary Purpose

Sacroiliitis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tomosynthesis of SI joints
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sacroiliitis focused on measuring Sacroiliitis, SI joint, tomosynthesis, CT, Xray

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Imaging department- University hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tomosynthesis

Arm Description

Tomosynthesis of SI joints

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

radiation dose
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
Inter reader agreement will be measured at retrospective evaluation.

Full Information

First Posted
September 27, 2018
Last Updated
September 26, 2019
Sponsor
University Hospital, Montpellier
Collaborators
DMS Apelem, Thales, Digisens, Medecom, BPIfrance, European Regional Development Fund
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1. Study Identification

Unique Protocol Identification Number
NCT03689881
Brief Title
Value of Tomosynthesis for the Detection of Sacro-iliitis (TOMOS SI)
Acronym
TOMOS SI
Official Title
Value of Tomosynthesis for Detection of Sacro-iliitis: a Prospective Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
DMS Apelem, Thales, Digisens, Medecom, BPIfrance, European Regional Development Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliitis
Keywords
Sacroiliitis, SI joint, tomosynthesis, CT, Xray

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tomosynthesis
Arm Type
Experimental
Arm Description
Tomosynthesis of SI joints
Intervention Type
Device
Intervention Name(s)
Tomosynthesis of SI joints
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of bone erosions and other structural lesions of SI joints
Description
sacroiliitis will be assessed independently for each imaging modality according to the modified New York criteria
Time Frame
1 day of enrollment
Secondary Outcome Measure Information:
Title
radiation dose
Description
Radiation dose will be measured for each imaging evaluation and calculated as the effective dose in millisievert (mSv).
Time Frame
1 day of enrollment
Title
inter reader agreement for the evaluation of sacroiliitis at tomosynthesis
Description
Inter reader agreement will be measured at retrospective evaluation.
Time Frame
at the end of patients enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Cyteval, MD, PhD
Phone
+ 33 4 67 33 81 78
Email
c-cyteval@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Cyteval, MD, PhD
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imaging department- University hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Lefebvre
Phone
+33 4 67 33 86 07
Email
s-lefebvre@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Celine Engrand
Phone
+33 4 67 33 86 07
Email
c-engrand@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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