MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(RBC-02)

Sun Yat-sen University

Status: Enrolling

Conditions: Radiomics; Neoadjuvant Chemotherapy; Axillary Lymph Node; Prognosis; Invasive Breast Cancer

Treatments: Other: No interventions

Study type: Observational

Funder types: Other

Identifiers

NCT04004559

SYSEC-KY-KS-2019-055-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Primary lesion diagnosed as invasive breast cancer;
2. Imaging examination confirmed no distant organ metastasis;
3. Received neoadjuvant chemotherapy for drugs such as taxanes, anthracyclines, and platinum as planned;
4. Completed breast MRI examination before or after neoadjuvant chemotherapy;
5. Accepted breast cancer surgery and axillary lymph node dissection;
6. Eastern Cooperative Oncology Group performance status 0-2.

Exclusion criteria

1. History of ipsilateral axillary or breast surgery;
2. Inflammatory breast cancer;
3. Bilateral breast cancer;
4. Malignant tumor history in 5 years;
5. Patients with cervical or contralateral axillary lymph node metastasis;
6. Incomplete imaging or medical history data.

Trial design

600 participants in 3 patient groups

Sun Yat-Sen Memorial Hospital of Sun Yat-sen University

Description:

Cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the training cohort.

Treatment:

Other: No interventions

Sun Yat-sen University Cancer Center

Description:

Cohort of Sun Yat-sen University Cancer Center is validation cohort 1.

Treatment:

Other: No interventions

Tungwah Hospital of Sun Yat-Sen University

Description:

Cohort of Tungwah Hospital of Sun Yat-Sen University is validation cohort 2.

Treatment:

Other: No interventions