Ultrasound Monitoring of Clipped Lymph Nodes to Predict Axillary Response After Chemotherapy in Breast Cancer
A Prospective Diagnostic Clinical Study Based on Longitudinal Multimodal Ultrasound Evaluation of Clipped Lymph Nodes to Assess Axillary Pathological Response After Neoadjuvant Chemotherapy in Breast Cancer
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Jingsi Mei
- 电话号码：+8618825050526
- 邮箱：meijs@mail.sysu.edu.cn
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510000
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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接触：
- Jingsi Mei
- 电话号码：+862081332066
- 邮箱：meijs@mail.sysu.edu.cn
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
Patients with histologically confirmed invasive breast cancer and biopsy-proven metastatic axillary lymph nodes who will receive standard neoadjuvant chemotherapy.
All enrolled patients will have a metallic clip placed in the biopsied positive lymph node before treatment, undergo longitudinal multimodal ultrasound examinations during and after NAC, and finally receive surgery with postoperative pathological evaluation of axillary lymph nodes.
描述
Inclusion Criteria:
- Female patients aged 18 years or older.
Clinical stage of breast cancer: T1-T4, N1-N3, M0.
Axillary lymph node metastasis confirmed by fine-needle aspiration (FNA) or core-needle biopsy.
Indicated for and planned to receive standard neoadjuvant chemotherapy (NAC) regimen.
The biopsy-proven metastatic lymph node is clearly visible on ultrasound and suitable for clip placement.
Completion of NAC followed by breast surgery and axillary lymph node dissection, with complete pathological results available.
Underwent multimodal ultrasound monitoring during NAC, including conventional ultrasound, elastography, and contrast-enhanced ultrasound.
Signed informed consent and willingness to complete all scheduled follow-ups.
Exclusion Criteria:
- Bilateral breast cancer.
Patients who are not suitable for neoadjuvant chemotherapy or plan to receive endocrine or targeted therapy only.
Prior breast or axillary surgery, chemotherapy, or other treatments that may affect the current therapeutic assessment.
Presence of distant metastasis or extensive axillary invasion making clip placement or evaluation difficult.
Pregnant or lactating women.
Poor image quality on ultrasound or other imaging modalities.
Inability to provide informed consent due to psychological, family, or social factors
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Breast cancer patients with clipped axillary lymph nodes receiving NAC and ultrasound follow-up.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR)
大体时间：At the time of postoperative pathological assessment (usually within 1 week after surgery)
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Area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the multimodal ultrasound-based predictive model for ax-pCR.
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At the time of postoperative pathological assessment (usually within 1 week after surgery)
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Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR)
大体时间：At the time of postoperative pathological assessment (usually within 1 week after surgery).
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Area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the multimodal ultrasound-based predictive model for ax-pCR.
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At the time of postoperative pathological assessment (usually within 1 week after surgery).
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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