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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Ultrasound
• Intervention / Treatment: Device: Screening of the subjects was conducted using an ultrasonic robot.

• Study Type: Interventional
• Enrollment (Estimated): 70000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoxv Yin, Doctor; Phone Number: 86+13871187781; Email: yxx@hust.edu.cn

Study Locations

• China
  • Hubei
    • Xiantao, Hubei, China, 433000
      • Recruiting
      • Rural health centers and community health centers
      • Contact: Xiaoxv Yin, Doctor; Phone Number: 86+13871187781; Email: yxx@hust.edu.cn
      • Contact: Email: yxx@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group: Using an ultrasound robot to screen the subjects	Device: 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.
No Intervention: The subjects are scanned with traditional hand-held ultrasound.; The subjects are scanned with traditional hand-held ultrasound.The images are diagnosed by radiologists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer type	Non-invasive cancer (DCIS), early invasive cancer, and invasive cancer.	After participating in the screening, the subjects will be followed up for 24 months.
The early diagnosis rate	The early diagnosis rate is defined as the number of breast cancer cases with TNM stage 0, I, or IIa divided by the number of women diagnosed with breast cancer or other malignant breast tumors during screening*100.	After participating in the screening, the subjects will be followed up for 24 months.
Lymph node status	Presence of lymph node metastasis; size, morphology, internal structure, margin characteristics, and vascularity of metastatic lymph nodes.	After participating in the screening, the subjects will be followed up for 24 months.
Breast cancer clinical stage	TNM staging, representing tumor size (T), lymph node involvement (N), and distant metastasis (M).	After participating in the screening, the subjects will be followed up for 24 months.
Histological Grading of Breast Cancer	The internationally accepted Nottingham Histological Grading System is used. This system provides a semi-quantitative and objective assessment of invasive breast cancer. It evaluates three parameters: the proportion of tubule formation, nuclear pleomorphism, and mitotic count. The scores of the three parameters are added together. A total score of 3-5 indicates Grade 1 (G1, well-differentiated/low grade). A total score of 6-7 indicates Grade 2 (G2, moderately differentiated/intermediate grade). A total score of 8-9 indicates Grade 3 (G3, poorly differentiated/high grade).	After participating in the screening, the subjects will be followed up for 24 months.
Breast cancer screen recall rate	Breast cancer screen recall is defined as further assessment triggered by abnormal ultrasound findings (BI-RADS 0 or 3 and above). The recall rate is the number of women actually recalled divided by the number of women screened.	After participating in the screening, the subjects will be followed up for 24 months.
The positive predictive value	The positive predictive value of recall is the percentage of recalled women who are diagnosed with breast cancer.	After participating in the screening, the subjects will be followed up for 24 months.
The breast cancer biopsy rate	The breast cancer biopsy rate is defined as the number of women who actually underwent biopsy divided by the number of women screened. The positive predictive value of biopsy is defined as the percentage of women diagnosed with breast cancer among those who received a biopsy.	After participating in the screening, the subjects will be followed up for 24 months.
Referral adherence rate	Defined as the average adherence to recommended referral for confirmed diagnosis (biopsy and histopathology). It is calculated as the number of women actually referred divided by the number of women recommended for referral.	After participating in the screening, the subjects will be followed up for 24 months.
Interval cancer incidence	Defined as the proportion of women who had a negative or false-positive screening (i.e., no ductal carcinoma in situ or invasive breast cancer) and were subsequently diagnosed with invasive breast cancer within a certain period after screening. Following the national breast cancer screening guideline recommending screening every 2-3 years, this study will evaluate the interval cancer incidence at 24 months, i.e., the proportion of women diagnosed with breast cancer 24 months after a negative screen or 6-24 months after a false-positive screen.	After participating in the screening, the subjects will be followed up for 24 months.
Breast cancer mortality	Defined as the number of deaths due to breast cancer within 24 months after screening divided by the total number of women screened.	After participating in the screening, the subjects will be followed up for 24 months.
All-cause mortality	Defined as the total number of deaths from any cause within 24 months after screening divided by the total number of women screened.	After participating in the screening, the subjects will be followed up for 24 months.
Post-screening management adherence	Defined as the proportion of women who completed the recommended follow-up medical actions after screening (referral, re-examination, additional tests, etc.). The adherence rate is calculated as the number of participants who completed the recommended management within the specified time / the number of participants requiring further management * 100%.	After participating in the screening, the subjects will be followed up for 24 months.

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2025
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 10, 2026

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: December 28, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: HuazhongU20251203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No