Multimodal Assessment of Malignancy in Atypia of Undetermined Significance in Thyroid Nodules Using Ultrasound and Cytology Whole-Slide Images

March 30, 2026 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The prospective study aim to develop a multimodal deep learning model that integrates ultrasound images and cytological whole-slide images for more accurate malignant risk prediction of Bethesda III thyroid nodules.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives: To develop a multimodal deep learning model that integrates ultrasound images and cytological whole-slide images for more accurate malignant risk prediction of Bethesda III thyroid nodules.

Materials and Methods: A ultrasound model, a cytology model, and a fusion model were constructed in this single-center retrospective diagnostic accuracy test. Consecutive patients with Bethesda III thyroid nodules who underwent conventional US examination and fine-needle aspirations were included between January 2016 and December 2024 in Sun Yat-sen Memorial Hospital, Sun Yat-sen University. The reference standard was postoperative histopathology or BRAFV600E mutation. Receiver operating characteristic curve analysis was used to evaluate the diagnostic performance, and decision curve analysis was used to assess the clinical utility.

Study Type

Observational

Enrollment (Estimated)

396

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Xinmin Xiao, B.S.
  • Phone Number: +8618420058253

Study Locations

  • China
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510288
        • Recruiting
        • No. 33 Yingfeng Road, Haizhu District, Guangzhou City, Guangdong Province, Sun Yat-sen Memorial Hospital
        • Contact:
        • Contact:

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

Sampling Method

Probability Sample

Study Population

Patients with a Bethesda Ⅲ thyroid nodule

Description

Inclusion Criteria:

  • (a) Patients who underwent fine-needle aspiration of thyroid nodules and received a cytological diagnosis of Bethesda Ⅲ.
  • (b) Patients who subsequently underwent thyroid surgery with a definitive histopathological diagnosis of benign or malignant lesions,.
  • (c) Availability of at least one ultrasound image acquired prior to surgery.

Exclusion Criteria:

  • (a) Patients without confirmation by surgical pathology,.
  • (b) Patients without any available or usable 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Benign thyroid nodule
Confirmed by histopathology.
Other: Histopathology or cytopathology.
This is a observation stufy.
Malignant thyroid nodule
Confirmed by histopathology.
Other: Histopathology or cytopathology.
This is a observation stufy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological diagnosis.
Time Frame: One month after the surgery.
WHO guidelines.
One month after the surgery.

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, Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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)

March 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSEC-AF-SW09-06.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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