Computed Tomography-based Radiomics of Axillary Lymph Node Pathological Complete Remission (ypN0) in Breast Cancer Undergoing Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- The features of CT-based radiomics for axillary lymph node achieved pCR after neoadjuvant chemotherapy
研究概览
简要总结
This is a prospective, single-center, non-randomized, non-controlled observational study.
详细描述
Almost 55-62% of patients with triple-negative or human epidermal growth factor receptor 2 (HER2) positive, node-positive breast cancer achieve an axillary pathologic complete remission (pCR) after neoadjuvant chemotherapy (NAC). To avoid surgery post-NAC, it is paramount to accurately identify patients who achieve pCR in axillary lymph node (ALN). We found that patients with normal-appearing lymph nodes on computed tomography (CT) based radiomics of the axilla after chemotherapy had a lower risk of developing residual nodal disease. However, the features of CT-based radiomics for pCR ALN following NAC has not been established yet. This study aimed to assess the performance of CT-based radiomics in evaluating the response and predicting pCR of metastatic lymph nodes after NAC in breast cancer patients.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Triple-negative or HER2-positve invasive breast cancer with axillary lymph node metastasis by confirmed by fine needle aspiration or core needle biopsy.
- •Underwent computed tomography for assessment of axillary lymph node status before and after neoadjuvant chemotherapy.
- •Attend the study voluntarily, sign the informed consent.
排除标准
- •Contradiction for adjuvant chemotherapy.
- •Contradiction for proceeding surgery.
结局指标
主要结局
The features of CT-based radiomics for axillary lymph node achieved pCR after neoadjuvant chemotherapy
时间窗: within 8 weeks after obtaining the post-surgery pathological results
Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of CT-based radiomics for axillary lymph node status after neoadjuvant chemotherapy will be assessed.
次要结局
- Receiver operating characteristic (ROC) curve analysis(within 8 weeks after obtaining the post-surgery pathological results)
研究者
Tao OUYANG
Director of Breast Center of Peking University Cancer Hospital
Peking University