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

NCT07331363 | Recruiting

• 1 other identifier: HuazhongU20251203
• Study Type: interventional
• Target: 70,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The detection rate of breast cancer

  Number of detected ductal carcinoma in situ (DCIS) and invasive breast cancers divided by the total number of screened participants.

  After participating in the screening, the subjects will be followed up for 24 months.

Secondary Outcomes (13)

• Cancer type

  After participating in the screening, the subjects will be followed up for 24 months.

• The early diagnosis rate

  After participating in the screening, the subjects will be followed up for 24 months.

• Lymph node status

  After participating in the screening, the subjects will be followed up for 24 months.

• Breast cancer clinical stage

  After participating in the screening, the subjects will be followed up for 24 months.

• Histological Grading of Breast Cancer

  After participating in the screening, the subjects will be followed up for 24 months.

Study Arms (2)

Intervention group: Using an ultrasound robot to screen the subjects

EXPERIMENTAL

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

The subjects are scanned with traditional hand-held ultrasound.

NO INTERVENTION

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

Interventions

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

Intervention group: Using an ultrasound robot to screen the subjects

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Rural health centers and community health centers

Xiantao, Hubei, 433000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xiaoxv Yin, Doctor

CONTACT

86+13871187781; yxx@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

CN (1)