Clinical trial · Interventional
Artificial Intelligence-assisted Contrast-enhanced Ultrasound Diagnosis of Thyroid Nodules
A Multicenter Study of Artificial Intelligence-assisted Contrast-enhanced Ultrasound Diagnosis of Thyroid Nodules
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this intervention study is to learn about the diagnostic performance of artificial intelligence to assist the contrast-enhanced ultrasound diagnosis of thyroid nodules. The main questions it aims to answer are: 1. Can we develop an artificial intelligence model to assist the contrast-enhanced ultrasound diagnosis of thyroid nodules? 2. Can artificial intelligent reduce the unnecessary biopsy of thyroid nodules? Participants will be asked to undergo contrast-enhanced ultrasound examination and ultrasound-guided fine-needle aspiration of thyroid nodules. Researchers will calculate the diagnostic performance of the contrast-enhanced ultrasound diagnosis of thyroid nodules with and without artificial intelligent assistance.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artificial Intelligence | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Test set
- description
- Participants with thyroid nodules underwent contrast-enhanced ultrasound and ultrasound-guided fine-needle aspiration during January 2021 and December 2022 in Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Houjie Hospital of Dongguan and Affiliated Huadu Hospital of Southern Medical University.
- interventionNames
- Other: Artificial Intelligence
Primary outcomes (2)
- measure
- Diagnostic performance
- timeFrame
- First week after primary completion date.
- description
- Sensitivity, specificity, positive predictive value, negative predictive value, accuracy, area under the curve
- measure
- The necessity of biopsy
- timeFrame
- First week after primary completion date.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with thyroid nodules with a solid component ≥5 mm confirmed by conventional ultrasound; * Patients who underwent conventional ultrasound, contrast-enhanced ultrasound, and fine-needle aspiration biopsy; * Patients with a final benign or malignant pathological results. Exclusion Criteria: * Patients with cytopathology of Bethesda I, III, or IV and without final benign or malignant pathology； * Patients with a history of thyroid ablation or surgery; * Patients with low-quality ultrasound images.
References
Publications (19)
- BACKGROUNDHaugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020. PMID 26462967
- BACKGROUNDBurgos N, Ospina NS, Sipos JA. The Future of Thyroid Nodule Risk Stratification. Endocrinol Metab Clin North Am. 2022 Jun;51(2):305-321. doi: 10.1016/j.ecl.2021.12.002. Epub 2022 May 4. PMID 35662443
- BACKGROUNDZhou J, Yin L, Wei X, Zhang S, Song Y, Luo B, Li J, Qian L, Cui L, Chen W, Wen C, Peng Y, Chen Q, Lu M, Chen M, Wu R, Zhou W, Xue E, Li Y, Yang L, Mi C, Zhang R, Wu G, Du G, Huang D, Zhan W; Superficial Organ and Vascular Ultrasound Group of the Society of Ultrasound in Medicine of the Chinese Medical Association; Chinese Artificial Intelligence Alliance for Thyroid and Breast Ultrasound. 2020 Chinese guidelines for ultrasound malignancy risk stratification of thyroid nodules: the C-TIRADS. Endocrine. 2020 Nov;70(2):256-279. doi: 10.1007/s12020-020-02441-y. Epub 2020 Aug 21. PMID 32827126
- BACKGROUNDTessler 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. PMID 28372962
- BACKGROUNDRuss G, Bonnema SJ, Erdogan MF, Durante C, Ngu R, Leenhardt L. European Thyroid Association Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules in Adults: The EU-TIRADS. Eur Thyroid J. 2017 Sep;6(5):225-237. doi: 10.1159/000478927. Epub 2017 Aug 8. PMID 29167761