Using ultra-high frequency ultrasound to diagnose Sjögren's syndrome
Ultra-High Frequency Ultrasonography (UHFUS) Evaluation of Salivary Glands in Patients With Suspected Sjögren's Syndrome
NA · University of Pisa · NCT06338735
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pisa (other) |
| Locations | 1 site (Pisa) |
| Trial ID | NCT06338735 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant, breastfeeding, or have conditions that limit their ability to participate will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pisa
- University of Pisa — Pisa, Italy (RECRUITING)
Study contacts
- Study coordinator: Rossana Izzetti
- Email: rossana.izzetti@unipi.it
- Phone: +39050993037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sjogren's Syndrome, ultra-high frequency ultrasonography, diagnostic imaging, Sjogren's syndrome, salivary glands