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

Vastra Gotaland Region

Status: Completed

Conditions: Thyroid Nodule; Thyroid Cancer

Treatments: Diagnostic Test: Non-selective cytology

Study type: Interventional

Funder types: Other

Identifiers

NCT05583097

Ultracyt 1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 195 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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195 participants in 2 patient groups

Selective cytology according to EU-TIRADS

No Intervention group

Description:

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

Non-selective cytology

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Non-selective cytology