Axillary Lymph Node, Breast Neoplasm Female, Early-stage Breast Cancer, Radiomics, Survival, Prosthesis
Conditions
Keywords
Early-stage Breast Cancer, Radiomics, Axillary lymph node metastasis, Tumor microenvironment, Survival, Deep learning
Brief summary
This bi-directional, multicentre study aims to assess multiparametric MRI Radiomics-based prediction model for identifying metastasis lymph nodes and prognostic prediction in breast cancer.
Detailed description
Sensitivity for prediction of lymph node metastasis and survival of currently available prognostic scores in limited. This study proposes to establish a deep learning algorithms of multiparametric MRI radiomics and nomogram for identifying lymph node metastasis and prognostic prediction of breast cancer. The study will investigate the relationship between the radiomics and the tumor microenvironment. The study includes the construction of multiparametric MRI radiomics-based prediction model and the validation of the prediction model.
Interventions
As this is a patient registry, there are no interventions.
Sponsors
Study design
Eligibility
Inclusion criteria
* The primary lesion was diagnosed as invasive breast cancer * Patients can have regional lymph node metastasis,but no distant organ metastasis * Complete the breast MRI examination before treatment * Accept breast cancer surgery or lymph node biopsy * Eastern Cooperative Oncology Group performance status 0-2
Exclusion criteria
* Inflammatory breast cancer * Accompanied with other primary malignant tumors * Perform surgery,radiotherapy and lymph node biopsy before breast MRI examination * Patients who have neoadjuvant chemotherapy * Patients had distant and contralateral axillary lymph node metastasis * The pathologic diagnosis was extensive ductal carcinoma in situ
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival (DFS) | 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The correlation of radiomics features and tumor microenvironment | baseline (Completed MRI data before biopsy,surgery,neoadjuvant and radiotherapy.) | Radiomics is a tool to analyze tumor microenvironment characteristics based on breast MRI images. |
| Lymph node metastasis | Baseline | The value of Radiomics of multiparametric MRI in predicting axillary lymph node metastasis. |
| Overall survival (OS) | 5 years | The association between Radiomics of multiparametric MRI and overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes. |
| Beast cancer specific motality (BCSM) | 5 years | Defined as time between randomization and the time of death occur specific due to breast cancer |
| Recurrence free survival (RFS) | 5 years | defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred |
Countries
China