Implications Of Posttreatment Changes In Axillary Lymph Nodes And Axillary Surgical Procedure Optimization In Breast Cancer Patients After Neoadjuvant Systemic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Residual Axillary Lymph Node Metastasis After NAST
研究概览
简要总结
The purpose of this study is to improve regional surgical treatment in breast cancer patients with axillary lymph node metastases (cN+) who received neoadjuvant systemic treatment (NAST) by using ultrasound elastography.
详细描述
This study aims to optimize regional surgical treatment in breast cancer patients with axillary lymph node metastases (cN+) after neoadjuvant systemic treatment (NAST). Ultrasound elastography will be validated as a method for identifying metastases or regressive posttreatment changes in removed axillary lymph nodes.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 years or older
- •Histologically confirmed breast cancer
- •Clinically positive axillary lymph nodes before neoadjuvant systemic treatment (cN+)
- •Completed neoadjuvant systemic treatment (NAST)
- •Planned axillary surgery (sentinel lymph node biopsy and/or axillary lymph node dissection)
- •Ability to provide written informed consent
排除标准
- •Age < 18 years
- •Male patients
- •Metastatic disease at diagnosis
- •Inflammatory breast cancer
- •New primary breast cancer
- •Bilateral breast cancer
- •Pregnancy
- •Previous breast or axillary surgery
研究组 & 干预措施
Ultrasound Elastography Assessment
Breast cancer patients with axillary lymph node metastases (cN+) after neoadjuvant systemic treatment undergo ultrasound elastography assessment to identify metastases or regressive changes in axillary lymph nodes.
干预措施: Ultrasound Elastography (Device)
结局指标
主要结局
Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Residual Axillary Lymph Node Metastasis After NAST
时间窗: Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (NAST).
Diagnostic accuracy of intraoperative ultrasound elastography performed on excised axillary lymph nodes for detection of residual metastatic disease after neoadjuvant systemic treatment (NAST), using histopathological examination of excised lymph nodes as the reference standard. Diagnostic performance will be reported as sensitivity (%), specificity (%), positive predictive value (PPV, %), and negative predictive value (NPV, %).
次要结局
- Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Regressive Posttreatment Changes in Axillary Lymph Nodes After NAST(Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (NAST).)