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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Sacroiliitis

Clinical Trial Details

NCT number	NCT03689881
Study type	Interventional
Source	University Hospital, Montpellier
Contact	Catherine Cyteval, MD, PhD
Phone	+ 33 4 67 33 81 78
Email	c-cyteval@chu-montpellier.fr
Status	Recruiting
Phase	N/A
Start date	October 4, 2018
Completion date	December 31, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05396495` - Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain	N/A
Completed	`NCT02425631` - CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System	N/A
Completed	`NCT02420041` - Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections	N/A
Enrolling by invitation	`NCT05916092` - Post-Market Clinical Study on a Modular SI Joint Fusion System
Completed	`NCT04314609` - Success Rate of Ultrasound Guided Sacroiliac Joint Injection in Sacroiliitis	N/A
Not yet recruiting	`NCT06034808` - Frequency of Sacroiliitis in Inflammatory Bowel Disease Patients Using MRI
Not yet recruiting	`NCT06053255` - Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis	N/A
Withdrawn	`NCT03992053` - Imaging for SIJ Injection Therapy	N/A
Completed	`NCT03122119` - Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint	Phase 4
Enrolling by invitation	`NCT05203926` - Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study	N/A
Recruiting	`NCT05715463` - Rheumatology-based Adaptive Intervention for Social Determinants and Health Equity	N/A
Completed	`NCT02098694` - Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis	N/A
Recruiting	`NCT05276024` - Evaluation of the iFuse Bedrock Technique in Association With Posterior Lumbosacral Fusion With Iliac Fixation.
Completed	`NCT01673633` - Sacroiliitis in Systemic Sclerosis	N/A
Enrolling by invitation	`NCT05712850` - Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device
Active, not recruiting	`NCT03631030` - Cooled RF Lesion MRI Characteristics	N/A
Completed	`NCT03834480` - Intraartecular Platelet Rich Plasma for Sacroiliitis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms