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

NCT ID: NCT07331363

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-10
• Study Completion Date: 2026-12-10

Brief 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.

Conditions

Breast Cancer; Ultrasound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Intervention group: Using an ultrasound robot to screen the subjects

Group Type: EXPERIMENTAL

Screening of the subjects was conducted using an ultrasonic robot.

Intervention Type: DEVICE

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.

The subjects are scanned with traditional hand-held ultrasound.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xiaoxv Yin, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rural health centers and community health centers

Xiantao, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoxv Yin, Doctor

Role: CONTACT

yxx@hust.edu.cn

86+13871187781

Facility Contacts

Xiaoxv Yin, Doctor

Role: primary

yxx@hust.edu.cn

86+13871187781

Role: backup

yxx@hust.edu.cn

Other Identifiers

HuazhongU20251203

Identifier Type: -

Identifier Source: org_study_id