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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-64
SponsorHuazhong University of Science and Technology

About this trial

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 criteria

Qualifiers

women aged 35-64 years

no history of breast cancer

ownership and ability to use a smartphone

willingness to participate in the screening program.

Disqualifiers

Women who have undergone breast removal surgery;

Pregnant and lactating women;

Women who have undergone breast cancer screening within the past year;

Trial design

Treatments tested in this trial

  • Screening of the subjects was conducted using an ultrasonic robot.

Treatment groups

70,000 Participants
are divided into 2 treatment groups