Novel Radiomics Signature on MRI Before and After Neoadjuvant Chemotherapy in Breast Cancer to Predict Axillary Lymph Node Metastasis and Prognosis (RBC-02)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
This study is aimed to illustrate whether Radiomics combining multiparametric MRI before and after neoadjuvant chemotherapy (NACT) with clinical data is a good way to predict axillary lymph node metastasis and prognosis in invasive-breast-cancer.
详细描述
This study proposes to build a clinical predictive model to predict axillary lymph node metastasis and prognosis in invasive-breast-cancer patients who received neoadjuvant chemotherapy before surgery. The model is built based on breast MRI signatures extracted and analyzed via deep machine-learning algorithm methods. Invasive breast cancer patients undergo multiparametric MRI at baseline, then undergo multiparametric MRI after received neoadjuvant chemotherapy for at least 4 cycles as planned. After the surgery, responses to neoadjuvant chemotherapy are determined according to the histopathologically examination of the surgically resected specimens. After completion of treatment procedure, patients are followed up for 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Primary lesion diagnosed as invasive breast cancer;
- •Imaging examination confirmed no distant organ metastasis;
- •Received neoadjuvant chemotherapy for drugs such as taxanes, anthracyclines, and platinum as planned;
- •Completed breast MRI examination before or after neoadjuvant chemotherapy;
- •Accepted breast cancer surgery and axillary lymph node dissection;
- •Eastern Cooperative Oncology Group performance status 0-2.
排除标准
- •History of ipsilateral axillary or breast surgery;
- •Inflammatory breast cancer;
- •Bilateral breast cancer;
- •Malignant tumor history in 5 years;
- •Patients with cervical or contralateral axillary lymph node metastasis;
- •Incomplete imaging or medical history data.
结局指标
主要结局
Disease free survival (DFS)
时间窗: 5 years
The association between Radiomics of multiparametric MRI and disease free survival (DFS), which defined as the time from the diagnosis of breast cancer to the confirmed time of metastatic disease, or death due to any other cause.
次要结局
- pathological complete response (pCR)(Pathologic evaluation will be performed for each patient within 1 week after surgery)
- Overall survival (OS)(5 years)
- Breast cancer specific motality (BCSM)(5 years)
- Pathological axillary lymph node status(Pathologic evaluation will be performed for each patient within 1 week after surgery)
- Recurrence free survival (RFS)(5 years)
研究者
Herui Yao
Principal Investigation
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University