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

CompletedOBSERVATIONAL
Enrollment

5,809

Participants

Timeline

Start Date

April 5, 2018

Primary Completion Date

May 4, 2020

Study Completion Date

May 4, 2020

Conditions
Women With Breast Cancer
Interventions
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.

Trial Locations (8)

100142

Beijing Cancer Hospital, Beijing

Unknown

Beijing Chao Yang Women and Children's Health Hospital, Beijing

Beijing Da Xing People's Hospital, Beijing

Beijing Hang Tian Centre Hospital, Beijing

Beijing Nan Jiao Cancer Hospital, Beijing

Beijing Shi Jing Shan Hospital, Beijing

Beijing Shun Yi Qu Hospital, Beijing

Beijing Shun Yi Woman and Children Health Hospital, Beijing

All Listed Sponsors
collaborator

Peking University

OTHER

lead

Peking University Cancer Hospital & Institute

OTHER

NCT03708978 - Development of Artificial Intelligence System for Detection and Diagnosis of Breast Lesion Using Mammography | Biotech Hunter | Biotech Hunter