The Ultracyt Study - is EU-TIRADS Useful in Selecting Nodules for Fine Needle Aspiration Cytology?
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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. |
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| 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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients referred to ultrasonography of the thyroid due to goiter symtoms or positive findings on FDG-PET
Exclusion Criteria:
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Patients previously examined with ultrasonography of the thyroid
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Patients who have previously undergone thyroid surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of radiology, Sahlgrenska University Hospital | Gothenburg | Sweden | 41345 |
Sponsors and Collaborators
- Vastra Gotaland Region
- Göteborg University
Investigators
- Principal Investigator: Andreas Muth, MD, PhD, Göteborg University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Cibas ES, Ali SZ. The 2017 Bethesda System for Reporting Thyroid Cytopathology. Thyroid. 2017 Nov;27(11):1341-1346. doi: 10.1089/thy.2017.0500.
- Russ G, Bonnema SJ, Erdogan MF, Durante C, Ngu R, Leenhardt L. European Thyroid Association Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules in Adults: The EU-TIRADS. Eur Thyroid J. 2017 Sep;6(5):225-237. doi: 10.1159/000478927. Epub 2017 Aug 8.
- Ultracyt 1.0