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

NCT05583097 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2025-04-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Andreas Muth, MD, PhD · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2023-12-20
Completion
2023-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05583097 on ClinicalTrials.gov