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

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.

NCT Number	NCT07296575
Lead Sponsor	Second Affiliated Hospital of Nanchang University Collaborators: First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Gannan Medical University, Ganzhou City 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, Fuyang people's hospital, General Hospital of Ningxia Medical University, Ji'an Central People's Hospital, Harbin First Specialized Hospital, Sun Yat-sen University, Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Yancheng First People's Hospital, Yangling Demonstration Zone Hospital of Shaanxi Province, Beijing Friendship Hospital, Fengfeng Mineral Bureau General Hospital of Hebei Province, Hunan Provincial Tumor Hospital, First Affiliated Hospital of Pingdingshan University, 908th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force, Bai Cheng Central Hospital, PLA No. 901 Hospital of the Joint Support Force, The Affiliated Hospital of Jinggangshan University, Ji'an Third People's Hospital
Conditions	Thyroid Abnormalities, Thyroid, Thyroid Cancer
Enrollment	2,000 participants
Start Date	2025-10-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-22