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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR)
研究概览
简要总结
This study aims to evaluate whether longitudinal multimodal ultrasound can accurately predict axillary pathological response in breast cancer patients who receive neoadjuvant chemotherapy. In this study, patients with biopsy-proven metastatic axillary lymph nodes will have a metallic clip placed in the positive node before chemotherapy. During and after treatment, the clipped lymph node will be monitored by ultrasound, including gray-scale imaging, shear wave elastography, and contrast-enhanced ultrasound. The changes in the morphological and functional features of the clipped node will be analyzed to establish a predictive model for axillary pathological complete response. The results are expected to help identify patients who may safely avoid unnecessary axillary lymph node dissection and improve individualized surgical decision-making.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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.
- •Clinical stage of breast cancer: T1-T4, N1-N3, M
- •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.
排除标准
- •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
研究组 & 干预措施
Breast cancer patients with clipped axillary lymph nodes receiving NAC and ultrasound follow-up.
结局指标
主要结局
Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR)
时间窗: At the time of postoperative pathological assessment (usually within 1 week after surgery)
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.
Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR)
时间窗: At the time of postoperative pathological assessment (usually within 1 week after surgery).
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.
次要结局
未报告次要终点