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| ID | Type | Description | Link |
|---|---|---|---|
| IIT-O-2025-343 | Registry Identifier | Multicenter Study on Ultrasound-Guided Intelligent Thyroid Parathyroid Fusion Technology Integrating Medical and Engine |
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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
| First Affiliated Hospital of Gannan Medical University | OTHER |
| Ganzhou City People's Hospital | OTHER |
| Tumor Hospital of Jiangxi Province |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Diagnostic Test | no Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive Performance of Large Models in Ultrasound Thyroid Applications for Thyroid Diseases | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with clinically suspected thyroid abnormalities who have been prescribed a thyroid ultrasound examination
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28372962 | Result | Tessler FN, Middleton WD, Grant EG, Hoang JK, Berland LL, Teefey SA, Cronan JJ, Beland MD, Desser TS, Frates MC, Hammers LW, Hamper UM, Langer JE, Reading CC, Scoutt LM, Stavros AT. ACR Thyroid Imaging, Reporting and Data System (TI-RADS): White Paper of the ACR TI-RADS Committee. J Am Coll Radiol. 2017 May;14(5):587-595. doi: 10.1016/j.jacr.2017.01.046. Epub 2017 Apr 2. | |
| 38372907 |
| Label | URL |
|---|---|
| Thyroid Cancer Diagnosis and Treatment Guidelines | View source |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| UNKNOWN |
| Chudong Medical Group Hospital (Yugan County) | UNKNOWN |
| Zhengzhou Third People's Hospital | UNKNOWN |
| Xuzhou Hospital of Traditional Chinese Medicine | UNKNOWN |
| Yifu Hospital Affiliated to Nanjing Medical University | UNKNOWN |
| Fuyang people's hospital | OTHER |
| General Hospital of Ningxia Medical University | OTHER |
| Ji'an Central People's Hospital | UNKNOWN |
| Harbin First Specialized Hospital | UNKNOWN |
| Sun Yat-sen University | OTHER |
| Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | UNKNOWN |
| Yancheng First People's Hospital | OTHER |
| Yangling Demonstration Zone Hospital of Shaanxi Province | UNKNOWN |
| Beijing Friendship Hospital | OTHER |
| Fengfeng Mineral Bureau General Hospital of Hebei Province | UNKNOWN |
| Hunan Provincial Tumor Hospital | UNKNOWN |
| Pingdingshan first people's Hospital | UNKNOWN |
| 908th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force | OTHER |
| Bai Cheng Central Hospital | UNKNOWN |
| PLA No. 901 Hospital of the Joint Support Force | OTHER |
| The Affiliated Hospital of Jinggangshan University | OTHER |
| Ji'an Third People's Hospital | UNKNOWN |
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| Result |
| de Carlos J, Garcia J, Basterra FJ, Pineda JJ, Dolores Ollero M, Toni M, Munarriz P, Anda E. Interobserver variability in thyroid ultrasound. Endocrine. 2024 Aug;85(2):730-736. doi: 10.1007/s12020-024-03731-5. Epub 2024 Feb 19. |
| 36909304 | Result | Patel J, Klopper J, Cottrill EE. Molecular diagnostics in the evaluation of thyroid nodules: Current use and prospective opportunities. Front Endocrinol (Lausanne). 2023 Feb 24;14:1101410. doi: 10.3389/fendo.2023.1101410. eCollection 2023. |
| D006258 |
| Head and Neck Neoplasms |