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Clinical Trials in France / NCT06235645
Recruiting Observational

dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound

NCT06235645 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-11-18
Last updated
2026-04-30

Condition(s) studied

Rheumatoid ArthritisInterstitial Lung DiseaseThoracic UltrasoundLung Ultrasound

Investigational drug(s) / intervention(s)

Lung ultrasound (LUS)

Lung ultrasound (LUS): If included, an LUS will be performed by an experienced operator, blinded to the results of the chest CT and PFT. A linear probe (4 to 12 MHz) will be used. The patient will be installed́ in a semi-seated position with the homolateral arm above the head for the anterior and axillary evaluation then, depending on his comfort, in a seated position or in right then left lateral decubitus, arms alongside the body, for the posterior evaluation. It will be practiced by experienced operators (pneumologist) and according to a validated protocol allowing the exploration of 14 intercostal spaces. LUT will be timed, recorded and anonymized. The operator will note the 3 ultrasound signs (total number of B lines, pleural line thickening and percentage of pleural line irregularity), their location and severity. The radiologist, on his part, will evaluate the patient's chest CT (gold standard), blinded to the results of the LUS, to make or not the diagnosis of RA-ILD.

Study summary

Rheumatoid arthritis is an autoimmune disease that can affect various organs, including the lungs, and lead to rheumatoid arthritis-interstitial lung disease (RA-ILD).

RA-ILD is responsible for increased mortality in rheumatoid arthristis (RA) patients.

The prevalence of RA-ILD varies according to the screening tool used.

The current gold standard is chest CT, but this is an expensive, time-consuming and irradiating examination, and recommendations on when and how often it should be performed are not clearly established.

Lung ultrasound (LUS) is an emerging tool for the detection of lung parenchymal damage, particularly in systemic scleroderma and idiopathic pulmonary fibrosis (IPF).

LUS is a non-irradiating, non-expensive examination that can be performed rapidly.

The aim of our study is to evaluate LUS as a screening tool for RA-ILD, in patients with risk factors for developing RA-ILD.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patient (age \> 18 years) followed at CHU of Tours * Diagnosis of rheumatoid arthritis validated according to ACR 2010 criteria, EULAR classification, regardless of time since diagnosis * Patient who has had or will have a thoracic CT scan and PFT performed as part of routine care in the 6 months preceding or following inclusion * Patient with at least two risk factors for developing RA-ILD among : * Male sex or * Active or former smoker assessed at 20 pack-year or * Age \> 60 years or * Levels of RF≥3N (rheumatoid factor) and/or anti-CCP≥3N (antibodies against cyclic citrullinated peptides) at diagnosis or at any time during the course of the disease or * High RA activity score (DAS28\>3.2) Exclusion Criteria: * Diagnosis of congenital lung disease * Diagnosis of another autoimmune pathology associated with RA (overlap syndrome) linked to the development of ILD (interstitial lung disease) (systemic sclerosis, myositis, dermatomyositis, mixed connectivitis, systemic lupus erythematosus or other ANCA vasculitis, with the exception of secondary Gougerot-Sjögren's syndromes). * Current or operated lung cancer * Thoracic irradiation * Thoracic transplant patients * Previous invasive thoracic procedures * Pathologies responsible for pleural thickening (silicosis, asbestosis, known pleural plaque, pleural sequelae of tuberculosis) * Pregnant or breast-feeding women * Patient under legal protection (guardianship, curatorship or safeguard of justice) * Patient who has objected to data processing * Parenchymal infection current or less than one month old prior to LUS examination * Liquid or gaseous pleural effusion

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
university hospital Tours Tours France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06235645 on ClinicalTrials.gov ↗ ← All trials in France