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

Breast Neoplasm Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04003558
• Other study ID #: SYSEC-KY-KS-2019-054-001
• Status: Recruiting
• Start date: May 28, 2019
• Est. completion date: January 1, 2025

Study information

• Verified date: August 2019
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Herui Yao, PhD
• Phone: +8613500018020
• Email: yaoherui[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: January 1, 2025
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Axillary Lymph Node
• Breast Neoplasm Female
• Breast Neoplasms
• Early-stage Breast Cancer
• Neoplasm Metastasis
• Prosthesis Failure
• Radiomics
• Survival, Prosthesis

Intervention

Other:
• No interventions
As this is a patient registry, there are no interventions.

Locations

Country	Name	City	State
China	Tungwah Hospital of Sun Yat-Sen University	Dongguan	Guangdong
China	Shunde hospital of southern medical university	Foshan	Guangdong
China	Sun Yat-Sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Zhongshan Ophthalmic Center, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Shunde Hospital of Southern Medical University, Sun Yat-sen University, Tungwah Hospital of Sun Yat-Sen University, Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival (DFS)	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.	5 years
Secondary	The correlation of radiomics features and tumor microenvironment	Radiomics is a tool to analyze tumor microenvironment characteristics based on breast MRI images.	baseline (Completed MRI data before biopsy,surgery,neoadjuvant and radiotherapy.)
Secondary	Lymph node metastasis	The value of Radiomics of multiparametric MRI in predicting axillary lymph node metastasis.	Baseline
Secondary	Overall survival (OS)	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.	5 years
Secondary	Beast cancer specific motality (BCSM)	Defined as time between randomization and the time of death occur specific due to breast cancer	5 years
Secondary	Recurrence free survival (RFS)	defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred	5 years