Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689881
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : September 27, 2019
Sponsor:
Collaborators:
DMS Apelem
Thales
Digisens
Medecom
BPI France
European Regional Development Fund
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Sacroiliitis Device: Tomosynthesis of SI joints Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Value of Tomosynthesis for Detection of Sacro-iliitis: a Prospective Comparative Study
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

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.





Primary Outcome Measures :
  1. Presence of bone erosions and other structural lesions of SI joints [ Time Frame: 1 day of enrollment ]
    sacroiliitis will be assessed independently for each imaging modality according to the modified New York criteria


Secondary Outcome Measures :
  1. radiation dose [ Time Frame: 1 day of enrollment ]
    Radiation dose will be measured for each imaging evaluation and calculated as the effective dose in millisievert (mSv).

  2. inter reader agreement for the evaluation of sacroiliitis at tomosynthesis [ Time Frame: at the end of patients enrollment ]
    Inter reader agreement will be measured at retrospective evaluation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689881


Contacts
Layout table for location contacts
Contact: Catherine Cyteval, MD, PhD + 33 4 67 33 81 78 c-cyteval@chu-montpellier.fr

Locations
Layout table for location information
France
Imaging department- University hospital Recruiting
Montpellier, France, 34295
Contact: Sophie Lefebvre    +33 4 67 33 86 07    s-lefebvre@chu-montpellier.fr   
Contact: Celine Engrand    +33 4 67 33 86 07    c-engrand@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
DMS Apelem
Thales
Digisens
Medecom
BPI France
European Regional Development Fund
Investigators
Layout table for investigator information
Principal Investigator: Catherine Cyteval, MD, PhD Montpellier University Hospital
Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03689881    
Other Study ID Numbers: RECHMPL18_0328
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Sacroiliitis
SI joint
tomosynthesis
CT
Xray
Additional relevant MeSH terms:
Layout table for MeSH terms
Sacroiliitis
Arthritis
Joint Diseases
Musculoskeletal Diseases