Artificial Intelligence-assisted Contrast-enhanced Ultrasound Diagnosis of Thyroid Nodules (AIA-CEUD-TN)

March 22, 2026 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

A Multicenter Study of Artificial Intelligence-assisted Contrast-enhanced Ultrasound Diagnosis of Thyroid Nodules

The goal of this intervention study is to learn about the diagnostic performance of artificial intelligence to assist the contrast-enhanced ultrasound diagnosis of thyroid nodules. The main questions it aims to answer are:

  1. Can we develop an artificial intelligence model to assist the contrast-enhanced ultrasound diagnosis of thyroid nodules?
  2. Can artificial intelligent reduce the unnecessary biopsy of thyroid nodules?

Participants will be asked to undergo contrast-enhanced ultrasound examination and ultrasound-guided fine-needle aspiration of thyroid nodules. Researchers will calculate the diagnostic performance of the contrast-enhanced ultrasound diagnosis of thyroid nodules with and without artificial intelligent assistance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1955

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510289
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Study population with the same indication for contrast-enhanced ultrasound and fine-needle aspiration biopsy:

  • Planned ablation or surgery;
  • At least one suspicious ultrasound feature, such as hypoechoic/very hypoechoic, irregular/lobulated margin, taller than wide, or punctate echogenic foci.

Description

Inclusion Criteria:

  • Patients with thyroid nodules with a solid component ≥5 mm confirmed by conventional ultrasound;
  • Patients who underwent conventional ultrasound, contrast-enhanced ultrasound, and fine-needle aspiration biopsy;
  • Patients with a final benign or malignant pathological results.

Exclusion Criteria:

  • Patients with cytopathology of Bethesda I, III, or IV and without final benign or malignant pathology；
  • Patients with a history of thyroid ablation or surgery;
  • Patients with low-quality ultrasound images.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Test set
Participants with thyroid nodules underwent contrast-enhanced ultrasound and ultrasound-guided fine-needle aspiration during January 2021 and December 2022 in Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Houjie Hospital of Dongguan and Affiliated Huadu Hospital of Southern Medical University.
Other: Artificial Intelligence
Artificial intelligence assisted contrast-enhanced ultrasound diagnosis of thyroid nodules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance
Time Frame: First week after primary completion date.
Sensitivity, specificity, positive predictive value, negative predictive value, accuracy, area under the curve
First week after primary completion date.
The necessity of biopsy
Time Frame: First week after primary completion date.
Unnecessary biopsy rate
First week after primary completion date.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Principal Investigator: Jingliang Ruan, PhD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2023

Primary Completion (Actual)

March 2, 2026

Study Completion (Actual)

March 16, 2026

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2023-702-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data generated or analyzed during the study are available from the principal investigator by request.

IPD Sharing Time Frame

The first week after the publication of the research papers.

IPD Sharing Access Criteria

Data generated or analyzed during the study are available from the principal investigator by request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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