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

Summary

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.

Conditions

• Thyroid Abnormalities
• Thyroid
• Thyroid Cancer

Interventions

DIAGNOSTIC_TEST

No intervention

no Intervention

Sponsors & Collaborators

• Zhejiang University

  collaborator OTHER

• First Affiliated Hospital of Gannan Medical University

  collaborator OTHER

• Ganzhou People's Hospital

  collaborator UNKNOWN

• Tumor Hospital of Jiangxi Province

  collaborator UNKNOWN

• Chudong Medical Group Hospital (Yugan County)

  collaborator UNKNOWN

• Zhengzhou Third People's Hospital

  collaborator UNKNOWN

• Xuzhou Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• Yifu Hospital Affiliated to Nanjing Medical University

  collaborator UNKNOWN

• Fuyang people's hospital

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• Ji'an Central People's Hospital

  collaborator UNKNOWN

• Harbin First Specialized Hospital

  collaborator UNKNOWN

• Sun Yat-sen University

  collaborator OTHER

• Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

  collaborator UNKNOWN

• Yancheng First People's Hospital

  collaborator OTHER

• Yangling Demonstration Zone Hospital of Shaanxi Province

  collaborator UNKNOWN

• Beijing Friendship Hospital

  collaborator OTHER

• Fengfeng Mineral Bureau General Hospital of Hebei Province

  collaborator UNKNOWN

• Hunan Provincial Tumor Hospital

  collaborator UNKNOWN

• Pingdingshan first people's Hospital

  collaborator UNKNOWN

• PLA Joint Logistics Support Force No. 908 Hospital

  collaborator UNKNOWN

• Bai Cheng Central Hospital

  collaborator UNKNOWN

• PLA Joint Logistics Support Force No. 901 Hospital

  collaborator UNKNOWN

• the Affiliated Hospital of Jinggangshan University

  collaborator UNKNOWN

• Ji'an Third People's Hospital

  collaborator UNKNOWN

• Second Affiliated Hospital of Nanchang University

  lead OTHER

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• China

Study Locations