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

Huazhong University of Science and Technology

Status: Enrolling

Conditions: Breast Cancer; Ultrasound

Treatments: Device: Screening of the subjects was conducted using an ultrasonic robot.

Study type: Interventional

Funder types: Other

Identifiers

NCT07331363

HuazhongU20251203

Details and patient eligibility

About

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.

Enrollment: 70,000 estimated patients

Sex: Female

Ages: 35 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70,000 participants in 2 patient groups

Intervention group: Using an ultrasound robot to screen the subjects

Experimental group

Treatment:

Device: Screening of the subjects was conducted using an ultrasonic robot.

The subjects are scanned with traditional hand-held ultrasound.

No Intervention group

Description:

The subjects are scanned with traditional hand-held ultrasound.The images are diagnosed by radiologists.