The goal of this clinical trial is to learn if robotic ultrasound screening works as well as or better than traditional sonographer-led screening for detecting breast cancer. It will also explore how well participants follow recommended post-screening care. The main questions it aims to answer are:
Does robotic ultrasound screening detect more cases of breast cancer compared to traditional sonographer-led screening? How well do participants follow up on recommended care after robotic ultrasound screening? Researchers will compare robotic ultrasound screening to traditional sonographer-led screening to see if robotic ultrasound works effectively for breast cancer screening.
Participants will:
Receive a breast ultrasound performed either by a robotic system or a human sonographer.
Undergo follow-up management based on their BI-RADS classification.
women aged 35-64 years
no history of breast cancer
ownership and ability to use a smartphone
willingness to participate in the screening program.
Women who have undergone breast removal surgery;
Pregnant and lactating women;
Women who have undergone breast cancer screening within the past year;
Parallel
Screening of the subjects was conducted using an ultrasonic robot.
DeviceThe ultrasound robot automatically scans the breasts of subjects via its mechanical arm and generates images.The diagnosis is made based on the radiologist's interpretation of the images.
The detection rate of breast cancer
Number of detected ductal carcinoma in situ (DCIS) and invasive breast cancers divided by the total number of screened participants.
Cancer type
Non-invasive cancer (DCIS), early invasive cancer, and invasive cancer.
The early diagnosis rate
The early diagnosis rate is defined as the number of breast cancer cases with TNM stage 0, I, or IIa divided by the number of women diagnosed with breast cancer or other malignant breast tumors during screening\*100.
Lymph node status
Presence of lymph node metastasis; size, morphology, internal structure, margin characteristics, and vascularity of metastatic lymph nodes.
Breast cancer clinical stage
TNM staging, representing tumor size (T), lymph node involvement (N), and distant metastasis (M).
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