Ultra-High Frequency Ultrasonography in Sjögren's Syndrome
Recruiting · NCT06338735 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Pisa
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Patients diagnosed with a diagnosis of Sjogren's syndrome performed according to the ACR/EULAR criteria will be included in the study. Sjogren's syndrome diagnosis will be performed following a complete diagnostic work-up involving rheumatologic assessment, glandular functional tests, and blood testing for anti-Ro(SSA) antibodies. Conventional ultrasonography of major salivary glands and ultra-high frequency ultrasonography (70 MHz) of minor salivary glands will be performed, and the scans assessed using the Outcome Measures in Rheumatology (OMERACT) scoring system (Score 0 normal glandular tissue, Score 1 mild glandular alteration, fine echogenicity or diffuse hypo-echogenicity, Score 2 moderate glandular alteration and focal hypoechoic areas with partial conservation of normal parenchyma, Score 3 diffuse presence of hypoechoic areas in the absence of normal glandular parenchyma with glandular fibrosis. Focus Score will be assessed following biopsy of minor salivary glands.
Who can take part
Inclusion criteria
- adults ≥ 18 years of age
- clinical suspect of Sjogren\'s syndrome
- acceptance to undergo complete Sjogren\'s Syndrome diagnostic work-up
- acceptance to be included in the study.
Exclusion criteria
- pregnancy or breastfeeding
- any acute or chronic condition that would limit the ability of the patient to participate in the study
- refusal to give informed consent
Where it is running
1 location listed.
- University of Pisa - Pisa, Italy