NCT06356441尚未招募不适用
Artificial Intelligence-supported Reading Versus Standard Double Reading for the Interpretation of Magnetic Resonance Imaging in the Detection of Local Recurrence for Nasopharyngeal Carcinoma: a Randomised Controlled Multicenter Study
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 10,400 人开始时间: 2024年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,400
- 试验地点
- 1
- 主要终点
- sensitivity
研究概览
简要总结
The aim of this randomized controlled study is to investigate whether the previously developed artificial intelligence model can triage post-radiotherapy magnetic resonance images of patients with nasopharyngeal carcinoma and assist radiologists in their interpretation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with treatment naive nasopharyngeal carcinoma who had finished radiotherapy for 6 months or more
- •The previous magnetic resonance imaging examination had showed complete remission in the primary site
- •Images are acquired using a 3T magnetic resonance imaging device, including unenhanced T1-weighted and T2-weighted sequences and contrast-enhanced T1-weighted sequences
排除标准
- •Patients are enrolled in this study for a specific magnetic resonance imaging scan and not for subsequent follow-up magnetic resonance imaging scans.
结局指标
主要结局
sensitivity
时间窗: through study completion, an average of 2 years
次要结局
- specificity(through study completion, an average of 2 years)
- total time of interpretation for all the MR images(through study completion, an average of 2 years)
- the rate of discussion with a third radiologist(through study completion, an average of 2 years)
- the sensitivity in the subgroups of different rT-stage(through study completion, an average of 2 years)
- the incidence of cases whose recurrent risks and contours cannot be provided by the AI model(through study completion, an average of 2 years)
- negative predictive value(through study completion, an average of 2 years)
- the detection rate of local recurrence in the AI-supported reading group(through study completion, an average of 2 years)
- positive predictive value(through study completion, an average of 2 years)
研究者
Fang-Yun Xie
professor
Sun Yat-sen University
研究点 (1)
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