NCT06340945招募中不适用
The Clinical Outcomes and Artificial Intelligence Prediction Model of Ultrasound-guided Thermal Ablation for the Treatment of Benign Thyroid Nodules：A Multicenter Prospective Study
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2024年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- rate of nodule regrowth
研究概览
简要总结
- To evaluate the clinical outcomes of ultrasound-guided thermal ablationfor the treatment of benign thyroid nodules;
- To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of benign thyroid nodules
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •[1]confirmation of benign nodule status on two separate fine- needle aspiration (FNA) or core-needle biopsy (CNB) [2]no suspicious malignant features on ultrasound examination [3]report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation [4]refusal or ineligibility for surgery [5]follow-up time ≥6months
排除标准
- •follicular neoplasm or malignancy findings on biopsy
- •nodules with benign result on biopsy had suspicious of malignancy in US, including marked hypoechoic, ill-defined margins, taller-than-wide shape or microcalcifications
- •patients with cystic nodules
- •patients with contra-lateral vocal cord par- alysis
- •previous radiation to the head and neck
- •; follow- up time less than 6 months
结局指标
主要结局
rate of nodule regrowth
时间窗: through study completion, an average of 1 months
Regrowth was defined as ≥50% volume increase compared to the previously recorded smallest volume during the follow-up
volume reduction rate
时间窗: through study completion, an average of 6 months
The volume reduction rate (VRR)was calculated by the equations: VRR=(\[initial volume-final volume\] × 100)/initial volume
次要结局
- rate of complications(1 week)
- symptom score(through study completion, an average of 6 months)
- total volume(through study completion, an average of 6 months)
- vital volume(through study completion, an average of 6 months)
- cosmetic score(through study completion, an average of 6 months)
研究者
Yu-kun Luo
Director, Head of Department of Ultrasound
Chinese PLA General Hospital
研究点 (1)
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