Prediction of Non-sentinel Lymph Node Metastatic Status of Breast Cancer Based on Pathology-MRI Images and Artificial Intelligence
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 700
- 主要终点
- Non-sentinel lymph node metastatic status
研究概览
简要总结
The goal of this observational study is to develop an artificial intelligence model based on pathology and magnetic resonance imaging (MRI) images to predict the metastatic status of non-sentinel lymph nodes in patients with breast cancer sentinel lymph node metastasis. The main questions it aims to answer are:
Can an artificial intelligence model based on MRI images of breast cancer patients predict the non-sentinel lymph node metastatic status in patients with breast cancer sentinel lymph node metastasis?
Can an artificial intelligence model based on intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastasis status in patients with sentinel lymph node metastasis from breast cancer?
Can artificial intelligence models based on preoperative MRI and intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastatic status in patients with sentinel lymph node metastasis from breast cancer?
Researchers will retrospectively and prospectively collect preoperative MRI and intraoperative sentinel lymph node section images from breast cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with primary breast cancer
- •Positive sentinel lymph node biopsy and axillary lymph node dissection.
- •No neoadjuvant chemotherapy, radiotherapy or ablation prior to surgery.
- •MRI within 3 weeks prior to surgery.
排除标准
- •recurrent breast cancer or history of surgery or radiation therapy in the axilla
- •Inflammatory breast cancer
- •Bilateral breast cancer or metastatic breast cancer
- •previous or current history of other malignant tumors
- •Sentinel lymph node count > 5
结局指标
主要结局
Non-sentinel lymph node metastatic status
时间窗: 2024-2025
metastasis or non-metastasis
Positive predictive value，Negative predictive value
时间窗: 2024-2025
The performance of predicting non-sentinel lymph node metastatic status
Accuracy, Sensitivity, Specificity，Area under the curve
时间窗: 2024-2025
The performance of predicting non-sentinel lymph node metastatic status
次要结局
未报告次要终点