Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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.

More Sjogren's Syndrome trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment800 (estimated)
SponsorUniversity of Pisa
Academic / other
Locations1 site (Pisa)
StatusRecruiting
StartedJanuary 11, 2016
Main results expectedDecember 31, 2026
Study endsDecember 2030
Registry record updatedJune 26, 2024
Trial IDNCT06338735 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.