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

March 25, 2025 updated by: Vastra Gotaland Region

Selective Ultrasound Guided Cytology Using EU-TIRADS Versus Non-selective Ultrasound Guided Cytology for Diagnosing Thyroid Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thyroid nodules are common in the population, and the reported incidence of thyroid cancer is increasing in most parts of the world. Palpable thyroid nodules are reported in 4-5 per cent of the population, of which 5-10 per cent are malignant. The reported incidence of thyroid nodules on ultrasound is higher.

EU-TIRADS has been shown in retrospective cohort studies to accurately stratify thyroid nodules with respect to risk of thyroid cancer. EU-TIRADS has been used in Western Sweden since 2017 and in 2021 it was implemented in the Swedish National Guidelines for thyroid cancer. To the knowledge of the investigators, no randomized controlled study has been carried out validating EU-TIRADS. This multicenter regional study aims to investigate the safety of using selective cytology using EU-TIRADS. Primary outcome is the result of cytology suspicious of thyroid cancer. In the selective group, low risk nodules will not undergo cytology and therefore the frequency of cytologically suspicious nodules (Bethesda III-VI) is expected to be higher in this group.

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 41345
        • Department of Radiology, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Selective cytology according to EU-TIRADS
All thyroid nodules are evaluated according to EU-TIRADS and cytology is performed according to EU-TIRADS criteria.
Active Comparator: Non-selective cytology
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of suspicious cytology (Bethesda III-VI) in each arm.
Time Frame: Through study completion, up to 18 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of malignancy
Time Frame: Through study completion, up to 18 months.
The frequency of malignancy is expected to be similar in both groups. Only patients undergoing surgery will be included in this analysis. The investigators do not expect to find statistical significance according to power calculations.
Through study completion, up to 18 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Collaborators

Göteborg University

Investigators

  • Principal Investigator: Andreas Muth, MD, PhD, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Actual)

December 20, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ultracyt 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD will be made available including data, study protocol, statistical analysis plan and informed consent form.

IPD Sharing Time Frame

Data will be available from six months to ten years after last patient inclusion in the study.

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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