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Ultra-High Frequency Ultrasonography in Sjögren's Syndrome

Ultra-High Frequency Ultrasonography (UHFUS) Evaluation of Salivary Glands in Patients With Suspected Sjögren's Syndrome

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06338735
Acronym
UltraSjögren
Enrollment
800
Registered
2024-04-01
Start date
2016-01-11
Completion date
2030-12-31
Last updated
2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren's Syndrome

Keywords

ultra-high frequency ultrasonography, diagnostic imaging, Sjogren's syndrome, salivary glands

Brief summary

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.

Detailed description

Primary Sjögren's syndrome is a complex autoimmune disease involving the exocrine salivary and lachrymal glands, with a progressive functional impairment caused by lymphocytic infiltration in the glandular tissue. The diagnosis is currently performed according to the criteria established in 2016 by the American College of Rheumatologists/European League Against Rheumatism (ACR/EULAR) and relies on 5 items, namely i) histologic Focus Score (FS) ≥1, ii) positivity to Anti-SSA (Ro) antibodies, iii) Ocular staining score ≥ 5 (or van Bijsterfeld score ≥ 4) on at least one eye, iv) Schirmer test ≤ 5 mm/5min on at least one eye and v) Unstimulated Salivary Flow Rate (USFR) ≤ 0.1 ml/min. Focus Score and positivity to antibodies are items with a weight of 3 points each, while the other items are assigned score 1. Diagnosis is performed with a total score ≥ 4 when summing the weights. While the improvement in the sensitivity of ACR/EULAR classification criteria by 5-10% has been previously reported for ultrasonography of major salivary glands, at present no evidence is available for minor salivary glands. Minor salivary glands ultrasonography with the use of ultra-high frequencies up to 70 MHz has been recently introduced in the diagnostic work-up of Sjögren's syndrome, and involves the assessment of glandular ultrasonographic structural alterations through the application of the Outcome Measures in Rheumatology (OMERACT) scoring system, which is routinely used for major salivary glands. The present study therefore aims to assess the correlation between minor salivary glands ultrasonography and ACR/EULAR items, in order to evaluate whether this technique may integrate the current evaluation of Sjögren's syndrome patients.

Interventions

OTHERUltra-High Frequency Ultrasound scan of minor salivary glands

Patients will undergo ultra-high frequency ultrasonography (70 MHz) of minor salivary glands, and the scans will be assessed using the OMERACT scoring system. Score 0 will be assigned in the presence of normal glandular tissue, Score 1 will correspond to mild glandular alteration, fine echogenicity or diffuse hypo-echogenicity, Score 2 will be assigned to moderate glandular alteration and focal hypoechoic areas with partial conservation of normal parenchyma, while in Score 3 diffuse presence of hypoechoic areas in the absence of normal glandular parenchyma with glandular fibrosis will be observed.

Sponsors

University of Pisa
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
OMERACT score1 monthEvaluation of ultrasonographic scans with the Outcome Measures in Rheumatology (OMERACT) scoring system, ranging between Score 0 (normal glandular tissue) and 3 (diffuse presence of hypoechoic areas in the absence of normal glandular parenchyma with glandular fibrosis )
Correspondence between ultrasonography and histology1 monthEvaluation of the concordance between ultrasonographic score of minor salivary glands assessed with Outcome Measures in Rheumatology (OMERACT) scoring system (scores 0-3) and histology

Countries

Italy

Contacts

Primary ContactRossana Izzetti
rossana.izzetti@unipi.it+39050993037

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026