A Multicenter Study of Artificial Intelligence-assisted Contrast-enhanced Ultrasound Diagnosis of Thyroid Nodules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,955
- 试验地点
- 1
- 主要终点
- Diagnostic performance
研究概览
简要总结
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:
- Can we develop an artificial intelligence model to assist the contrast-enhanced ultrasound diagnosis of thyroid nodules?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Cytopathologists, histopathologists and statistical analysts were blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Diagnostic performance
时间窗: First week after primary completion date.
Sensitivity, specificity, positive predictive value, negative predictive value, accuracy, area under the curve
The necessity of biopsy
时间窗: First week after primary completion date.
Unnecessary biopsy rate
次要结局
未报告次要终点