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

Condition(s) studied

Investigational drug(s) / intervention(s)

Screening 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.

Study 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

Primary outcome measure(s)

• The detection rate of breast cancer — After participating in the screening, the subjects will be followed up for 24 months.
  Number of detected ductal carcinoma in situ (DCIS) and invasive breast cancers divided by the total number of screened participants.

Trial sites (1)

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