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

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

NCT ID: NCT05583097

Condition: Thyroid Cancer
Thyroid Nodule

Conditions: Official terms:
Thyroid Neoplasms
Thyroid Nodule
Thyroid Diseases

Conditions: Keywords:
Ultrasonography
Cytology
Thyroid Cancer
Thyroid Nodule
Diagnostics

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomization 1:1 in blocks of 10.

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: Non-selective cytology
Description: 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.
Arm group label: Non-selective cytology

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Department of radiology, Sahlgrenska University Hospital

Address:
City: Gothenburg
Zip: 41345
Country: Sweden

Status: Recruiting

Contact:
Last name: Jeanette Carlqvist, MD
Email: jeanette.carlqvist@vgregion.se

Start date: February 15, 2022

Completion date: December 31, 2023

Lead sponsor:
Agency: Vastra Gotaland Region
Agency class: Other

Collaborator:
Agency: Göteborg University
Agency class: Other

Source: Vastra Gotaland Region

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05583097
https://pubmed.ncbi.nlm.nih.gov/29167761/
https://pubmed.ncbi.nlm.nih.gov/29091573/