Development of Artificial Intelligence System for Detection and Diagnosis of Breast Lesion Using Mammography

Peking University Cancer Hospital & Institute

Status: Completed

Conditions: Women With Breast Cancer

Treatments: Diagnostic Test: mammography

Study type: Observational

Funder types: Other

Identifiers

NCT03708978

BCA-AI

Details and patient eligibility

About

This project aims to establish a comprehensive artificial intelligence system for detecting and qualitative diagnosing breast lesions. Mammary images will be used to construct a diagnosis method based on deep learning. The system is proposed to automatically analyze the type of mammary glands, automatically identify and mark all breast lesions on the mammography images, provide the malignancy probability judgment of the lesions, the BI-RADS classification and the clinical suggestion, and also automatically generate the structured diagnosis report.

Full description

This is a multi-center study.The project contains a retrospective part(3000 samples anticipated) and a prospective part(7000 samples anticipated). In the retrospective part, investigators collected subjects with mammary images to design the deep learning method and construct a detective and diagnostic model for breast lesions. In the prospective part, investigators validate the accuracy of the constructed deep learning method, and established artificial intelligence system focusing on mammary diagnosis. Investigators will also explore the application pattern of the artificial intelligence system in clinical practice.

Enrollment: 5,809 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• the X-ray images of the breast were complete
• the results of pathological diagnosis or more than 2 years of mammography follow-up were available
• subject signs informed consent(this item was only for prospective study cases)

Exclusion criteria

• there exists pathological diagnosis of breast lesions when receiving mammography
• there lacks pathological diagnosis or 2 years of mammography follow-up
• subject withdraws(this item was only for prospective study cases)

Trial design

5,809 participants in 1 patient group

mammography group

Description:

women who receives mammography because of suspected breast lesion(s)

Treatment:

Diagnostic Test: mammography