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

Not Applicable

Completed

• Conditions: Thyroid Cancer; Thyroid Nodule
• Interventions: Diagnostic Test: Non-selective cytology

• Registration Number: NCT05583097
• Lead Sponsor: Vastra Gotaland Region

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.

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 Timeline

• Study Start: 2022-02-15
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-17
• Primary Completion: 2023-12-20
• Study Completion: 2023-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-selective cytology	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.

Primary Outcome Measures

Name	Time	Method
Frequency of suspicious cytology (Bethesda III-VI) in each arm.	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 Outcome Measures

Name	Time	Method
Frequency of malignancy	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.

Trial Locations

Locations (1)

Department of radiology, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden