Deep Learning Algorithms for Prediction of Lymph Node Metastasis and Prognosis in Breast Cancer MRI Radiomics (RBC-01)

Recruiting

• Conditions: Breast Neoplasm Female; Radiomics; Survival, Prosthesis; Early-stage Breast Cancer; Axillary Lymph Node
• Interventions: Other: No interventions

• Registration Number: NCT04003558
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Timeline

• Study Start: 2019-05-28
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-15
• Primary Completion: 2020-05-31
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sun Yat-sen University Cancer Center	No interventions	The cohort of Sun Yat-sen University Cancer Center is a validation cohort.
Sun Yat-Sen Memorial Hospital of Sun Yat-sen University	No interventions	The cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is a training cohort.
Tungwah Hospital of Sun Yat-Sen University	No interventions	The cohort of Tungwah Hospital of Sun Yat-Sen University is a validation cohort.
Shunde hospital of southern medical university	No interventions	The cohort of Shunde hospital of southern medical university is a validation cohort.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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.

Trial Locations

Locations (5)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Shunde hospital of southern medical university; 🇨🇳 Foshan, Guangdong, China

Zhongshan Ophthalmic Center, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Sun Yat-Sen Memorial Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Tungwah Hospital of Sun Yat-Sen University; 🇨🇳 Dongguan, Guangdong, China