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NCT Number: NCT05583097

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

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.

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms Thyroid Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of radiology, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Göteborg University

Registry information

Official study title

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

Acronym: Ultracyt

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 17, 2022
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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