Ultrasound Large-scale Model in Thyroid Field: A Multi-center Study on Medical-Engineering Integration

December 18, 2025 updated by: Chunquan Zhang, Second Affiliated Hospital of Nanchang University

A Multicenter Study on Multimodal Diagnosis and Process Optimization of Thyroid Diseases Based on Ultrasonic Intelligent Agents

The goal of this observational study is to evaluate the diagnostic accuracy and clinical workflow integration of an ultrasound intelligent agent (UIA) for thyroid disease management in a real-world multicenter setting. The primary research question is:

Can the UIA improve diagnostic consistency and efficiency for thyroid nodules (TI-RADS 1-5), Hashimoto's thyroiditis, and cervical lymph node metastasis compared to traditional ultrasound interpretation? Participants will include adults (18-80 years) undergoing thyroid ultrasound at 16 participating hospitals across China. Key inclusion criteria cover patients with suspected thyroid disorders requiring imaging, while exclusion criteria address poor image quality or concurrent clinical trials. Over 2,000 cases (50% thyroid nodules, 30% diffuse lesions, 12.5% non-nodular abnormalities, 7.5% special populations) will be prospectively enrolled. Data collection integrates static/dynamic ultrasound images, laboratory results, and AI-generated reports. Primary endpoints include model performance metrics (AUC, sensitivity/specificity, TI-RADS Kappa ≥0.8), workflow efficiency (report generation time ≤5 minutes), and pediatric/pregnancy-specific reference standards. Secondary analyses will assess inter-rater reliability (Cohen's Kappa) and longitudinal outcomes via 6-12-month follow-up. This study aims to establish evidence-based guidelines for AI-augmented thyroid diagnosis, particularly in underserved regions, while addressing gaps in current AI validation frameworks related to multi-modality data fusion and special population adaptability.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

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
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Second Affiliated Hospital of Nanchang 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with clinically suspected thyroid abnormalities who have been prescribed a thyroid ultrasound examination

Description

Inclusion Criteria:

  • Ages 18-80, clinically suspected thyroid disease (e.g., enlargement, nodules, pain) requiring ultrasound examination;
  • Diffuse lesions must demonstrate both ultrasound characteristics and laboratory evidence;
  • Dynamic video must fully cover the maximum diameter of the nodule without significant probe movement;
  • Voluntary signed informed consent.

Exclusion Criteria:

  • Poor image quality (severe gas interference, artifacts obscuring structural visualization);
  • Inability to cooperate with examination (consciousness impairment, extreme non-compliance);
  • Prior participation in other thyroid ultrasound-related clinical trials; postoperative thyroid recurrence;
  • Thyroid malformation/ectopia affecting visualization.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive Performance of Large Models in Ultrasound Thyroid Applications for Thyroid Diseases
Time Frame: Within 12 months of enrollment for each patient at the time of study completion.
Diagnosing thyroid diseases using a large model in the field of ultrasound thyroid imaging, with histopathological examination results of thyroid lesions as the gold standard, to evaluate the model's sensitivity, specificity, accuracy, and area under the receiver operating characteristic curve (AUC) for diagnosing thyroid diseases.
Within 12 months of enrollment for each patient at the time of study completion.

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital of Nanchang University

Collaborators

Sun Yat-sen University
Beijing Friendship Hospital
Zhejiang University
General Hospital of Ningxia Medical University
First Affiliated Hospital of Gannan Medical University
Yancheng First People's Hospital
Fuyang people's hospital
Pingdingshan first people's Hospital
Ganzhou People's Hospital
Ji'an Central People's Hospital
Tumor Hospital of Jiangxi Province
Chudong Medical Group Hospital (Yugan County)
Zhengzhou Third People's Hospital
Xuzhou Hospital of Traditional Chinese Medicine
Yifu Hospital Affiliated to Nanjing Medical University
Harbin First Specialized Hospital
Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Yangling Demonstration Zone Hospital of Shaanxi Province
Fengfeng Mineral Bureau General Hospital of Hebei Province
Hunan Provincial Tumor Hospital
PLA Joint Logistics Support Force No. 908 Hospital
Bai Cheng Central Hospital
PLA Joint Logistics Support Force No. 901 Hospital
the Affiliated Hospital of Jinggangshan University
Ji'an Third People's Hospital

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

Helpful Links

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)

October 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SecondNanchangU2025
  • IIT-O-2025-343 (Registry Identifier: Multicenter Study on Ultrasound-Guided Intelligent Thyroid Parathyroid Fusion Technology Integrating Medical and Engine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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