The Ultracyt Study - is EU-TIRADS Useful in Selecting Nodules for Fine Needle Aspiration Cytology?

NCT05583097 | Completed

• 1 other identifier: Ultracyt 1.0
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized study evaluating selective fine-needle aspiration cytology based on structured ultrasound using EU-TIRADS versus non-selective ultrasound guided cytology. Primary outcome is frequency of suspicious cytology (Bethesda III-VI) which is expected to be higher in the selective group compared to the non-selective group. Secondary outcome is the frequency of malignancy which is expected to be equal in both groups. However, the investigators do not expect to reach statistical significance for the secondary outcome according to power calculations.

Conditions

Thyroid Cancer; Thyroid Nodule

Keywords

Ultrasonography; Cytology; Thyroid Cancer; Thyroid Nodule; Diagnostics

Outcome Measures

Primary Outcomes (1)

• Frequency of suspicious cytology (Bethesda III-VI) in each arm.

  Fewer nodules in the selective cytology group will most likely undergo fine needle aspiration cytology (FNAC). However, since ultrasonographically benign nodules will not undergo FNAC the frequency of Bethesda III-VI is expected to be higher in the selective cytology group.

  Through study completion, up to 18 months.

Secondary Outcomes (1)

• Frequency of malignancy

  Through study completion, up to 18 months.

Study Arms (2)

Selective cytology according to EU-TIRADS

NO INTERVENTION

All thyroid nodules are evaluated according to EU-TIRADS and cytology is performed according to EU-TIRADS criteria.

Non-selective cytology

ACTIVE COMPARATOR

All thyroid nodules are evaluated according to EU-TIRADS and cytology is performed on all nodules \>1 cm. Cytology will also be performed on EU-TIRADS 5-nodules measuring between 0.5 and 1 cm.

Diagnostic Test: Non-selective cytology

Interventions

Non-selective cytology DIAGNOSTIC_TEST

All noduleas are evaluated according to EU-TIRADS. Cytology performed on all nodules larger than 1 cm regardless of ultrasonographic features. Nodules 1 cm or smaller evaluated as EU-TIRADS 5 undergo cytologic examination if possible.

Non-selective cytology

Eligibility Criteria

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

You may qualify if:

• Patients referred to ultrasonography of the thyroid due to goiter symtoms or positive findings on FDG-PET

You may not qualify if:

• Patients previously examined with ultrasonography of the thyroid
• Patients who have previously undergone thyroid surgery

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (1)

Department of radiology, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (2)

• Russ G, Bonnema SJ, Erdogan MF, Durante C, Ngu R, Leenhardt L. European Thyroid Association Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules in Adults: The EU-TIRADS. Eur Thyroid J. 2017 Sep;6(5):225-237. doi: 10.1159/000478927. Epub 2017 Aug 8.

  PMID: 29167761 BACKGROUND

• Cibas ES, Ali SZ. The 2017 Bethesda System for Reporting Thyroid Cytopathology. Thyroid. 2017 Nov;27(11):1341-1346. doi: 10.1089/thy.2017.0500.

  PMID: 29091573 BACKGROUND

Related Links

• EU-TIRADS description
• Updated description of the Bethesda system

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Nodule

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Andreas Muth, MD, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomization 1:1 in blocks of 10.

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 17, 2022
• Study Start: February 15, 2022
• Primary Completion: December 20, 2023
• Study Completion: December 31, 2023
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available from six months to ten years after last patient inclusion in the study.
• Access Criteria: Upon reasonable request data from the study will be made available by email to dr Jakob Dahlberg (jakob.dahlberg@vgregion.se) or dr Andreas Muth (andreas.muth@vgregion.se).

Locations

SE (1)