Ultra-High Frequency Ultrasonography in Sjögren's Syndrome

NCT06338735 | Recruiting

• 1 other identifier: 14540
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren's Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (2)

• OMERACT score

  Evaluation 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 )

  1 month

• Correspondence between ultrasonography and histology

  Evaluation of the concordance between ultrasonographic score of minor salivary glands assessed with Outcome Measures in Rheumatology (OMERACT) scoring system (scores 0-3) and histology

  1 month

Study Arms (1)

Sjogren's syndrome

EXPERIMENTAL

patients with Sjogren's syndrome diagnosed according to the ACR/EULAR criteria

Other: Ultra-High Frequency Ultrasound scan of minor salivary glands

Interventions

Ultra-High Frequency Ultrasound scan of minor salivary glands OTHER

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.

Sjogren's syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University of Pisa

Pisa, 56126, Italy

RECRUITING

Related Publications (9)

• Inanc N, Jousse-Joulin S, Abacar K, Cimsit C, Cimsit C, D'Agostino MA, Naredo E, Hocevar A, Finzel S, Pineda C, Keen H, Iagnocco A, Hanova P, Schmidt WA, Mumcu G, Terslev L, Bruyn GA. The Novel OMERACT Ultrasound Scoring System for Salivary Gland Changes in Patients With Sjogren Syndrome Is Associated With MRI and Salivary Flow Rates. J Rheumatol. 2024 Mar 1;51(3):263-269. doi: 10.3899/jrheum.2023-0202.

  PMID: 37914219 BACKGROUND

• Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts. Arthritis Rheumatol. 2017 Jan;69(1):35-45. doi: 10.1002/art.39859. Epub 2016 Oct 26.

  PMID: 27785888 BACKGROUND

• Brito-Zeron P, Baldini C, Bootsma H, Bowman SJ, Jonsson R, Mariette X, Sivils K, Theander E, Tzioufas A, Ramos-Casals M. Sjogren syndrome. Nat Rev Dis Primers. 2016 Jul 7;2:16047. doi: 10.1038/nrdp.2016.47.

  PMID: 27383445 BACKGROUND

• Ferro F, Izzetti R, Vitali S, Aringhieri G, Fonzetti S, Donati V, Dini V, Mosca M, Gabriele M, Caramella D, Baldini C. Ultra-high frequency ultrasonography of labial glands is a highly sensitive tool for the diagnosis of Sjogren's syndrome: a preliminary study. Clin Exp Rheumatol. 2020 Jul-Aug;38 Suppl 126(4):210-215. Epub 2020 Oct 23.

  PMID: 33095145 RESULT

• Donati V, Ferro F, Governato G, Fulvio G, Izzetti R, Nardini V, Baldini C. Total area of inflammatory infiltrate and percentage of inflammatory infiltrate identify different clinical-serological subsets of primary Sjogren's syndrome better than traditional histopathological parameters. Clin Exp Rheumatol. 2020 Jul-Aug;38 Suppl 126(4):195-202. Epub 2020 Oct 23.

  PMID: 33095147 RESULT

• Izzetti R, Ferro F, Vitali S, Nisi M, Fonzetti S, Oranges T, Donati V, Caramella D, Baldini C, Gabriele M. Ultra-high frequency ultrasonography (UHFUS)-guided minor salivary gland biopsy: A promising procedure to optimize labial salivary gland biopsy in Sjogren's syndrome. J Oral Pathol Med. 2021 May;50(5):485-491. doi: 10.1111/jop.13162. Epub 2021 Feb 15.

  PMID: 33501696 RESULT

• Fulvio G, Donati V, Izzetti R, Fonzetti S, La Rocca G, Ferro F, Baldini C. Correspondence between minor salivary glands ultra-high frequency ultrasonography and histology: a case report of severe/atypical lymphoid infiltrate in Sjogren's syndrome. Clin Exp Rheumatol. 2022 Dec;40(12):2474-2475. doi: 10.55563/clinexprheumatol/rdbm3h. Epub 2022 Dec 20. No abstract available.

  PMID: 36541238 RESULT

• Fulvio G, Izzetti R, Aringhieri G, Donati V, Ferro F, Gabbriellini G, Mosca M, Baldini C. UHFUS: A Valuable Tool in Evaluating Exocrine Gland Abnormalities in Sjogren's Disease. Diagnostics (Basel). 2023 Aug 26;13(17):2771. doi: 10.3390/diagnostics13172771.

  PMID: 37685309 RESULT

• Izzetti R, Fulvio G, Nisi M, Gennai S, Graziani F. Reliability of OMERACT Scoring System in Ultra-High Frequency Ultrasonography of Minor Salivary Glands: Inter-Rater Agreement Study. J Imaging. 2022 Apr 15;8(4):111. doi: 10.3390/jimaging8040111.

  PMID: 35448238 RESULT

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Rossana Izzetti

CONTACT

+39050993037; rossana.izzetti@unipi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher at the Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine of the University of Pisa, Principal Investigator

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 1, 2024
• Study Start: January 11, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)