NCT03708978

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,809 (actual)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Women With Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	mammography	When a woman comes to the clinic to receive mammography. Then a radiologist will give a BI-RADS classification after reviewing the images. If a BI-RADS 4/5 is obtained, the woman will receive pathological biopsy to ensure there is a benign or malignant lesion. If a BI-RADS 3 is obtained, the woman will be followed up by a half-year interval until two year after the first mammography. At each follow up, she will receive mammography. If a BI-RADS 4/5 is obtained at follow up, she will receive pathological biopsy; if a BI-RADS 1/2/3 is obtained at follow up, she will be followed up by a half-year interval until two year. If a BI-RADS 1/2 is obtained at the first mammography, the woman will receive a second mammography after two year. During the study period, breast examination and results will be recorded for every subject. Radiologists will give the diagnosis with and without AI support.

Timeline

• Start date: 2018-04-05
• Primary completion: 2020-05-04
• Completion: 2020-05-04
• First posted: 2018-10-17
• Last updated: 2021-07-27

Locations

8 sites across 1 country: China