RecruitingNot ApplicableNCT07331363

Evaluation of the Effect of Using Ultrasound Robots for Breast Cancer Screening: A Multicenter, Parallel-group, Cluster Randomized Controlled Trial

Sponsor

Huazhong University of Science and Technology

Enrollment

70,000 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Ultrasound

Summary

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.

Eligibility

Sex: FEMALEMin Age: 35 YearsMax Age: 64 Years

Inclusion Criteria4

women aged 35-64 years
no history of breast cancer
ownership and ability to use a smartphone
willingness to participate in the screening program.

Exclusion Criteria3

Women who have undergone breast removal surgery;
Pregnant and lactating women;
Women who have undergone breast cancer screening within the past year;

Interventions

DEVICEScreening of the subjects was conducted using an ultrasonic robot.

The 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.