Using ultra-high frequency ultrasound to diagnose Sjögren's syndrome
Official title: Ultra-High Frequency Ultrasonography (UHFUS) Evaluation of Salivary Glands in Patients With Suspected Sjögren's Syndrome
Run by University of Pisa · NCT06338735 · Data updated 2026-11-12
This study is testing if a new type of ultrasound can help doctors diagnose Sjögren's syndrome more accurately by looking at the small salivary glands in addition to the bigger ones.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | University of Pisa Academic / other |
| Locations | 1 site (Pisa) |
| Status | Recruiting |
| Started | January 11, 2016 |
| Main results expected | December 31, 2026 |
| Study ends | December 2030 |
| Registry record updated | June 26, 2024 |
| Trial ID | NCT06338735 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are clinically suspected of having Sjögren's syndrome and are willing to undergo a complete diagnostic work-up.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have conditions that limit their ability to participate will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study involves patients diagnosed with Sjögren's syndrome according to established criteria. It aims to enhance diagnostic accuracy by utilizing ultra-high frequency ultrasonography (70 MHz) to assess minor salivary glands, alongside conventional ultrasonography of major salivary glands. The scans will be evaluated using the OMERACT scoring system to determine glandular alterations. The study seeks to improve the sensitivity of Sjögren's syndrome diagnosis through advanced imaging techniques.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and earlier diagnosis of Sjögren's syndrome, improving patient management.
How similar studies have gone: While previous studies have shown improvements in diagnostic sensitivity for major salivary glands, the use of ultra-high frequency ultrasound for minor salivary glands is a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
University of Pisa
Pisa, Italy Recruiting
Study contacts
- Study coordinator: Rossana Izzetti
- Email: rossana.izzetti@unipi.it
- Phone: +39050993037
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.