Robotic versus sonographer breast ultrasound screening
Evaluation of the Effect of Using Ultrasound Robots for Breast Cancer Screening: A Multicenter, Parallel-group, Cluster Randomized Controlled Trial
This trial will see if robotic ultrasound can find breast cancer as well as or better than a human sonographer in women aged 35–64 and will check how well they follow recommended follow-up care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70000 (estimated) |
| Ages | 35 Years to 64 Years |
| Sex | Female |
| Sponsor | Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Xiantao, Hubei) |
| Trial ID | NCT07331363 on ClinicalTrials.gov |
What this trial studies
This multicenter, parallel-group, cluster randomized controlled trial in Xiantao, Hubei compares robotic ultrasound screening to traditional sonographer-performed breast ultrasound. Women aged 35–64 without prior breast cancer are assigned by site to receive either a robotic or human-performed ultrasound and their imaging is categorized using the BI-RADS system. Researchers will compare cancer detection rates between groups and track participants' adherence to recommended post-screening management. Screening is done at rural and community health centers, with pregnant or lactating women, those with prior mastectomy, or those screened within the past year excluded.
Who should consider this trial
Good fit: Women aged 35–64 who have no history of breast cancer, own and can use a smartphone, are willing to participate, and have not had breast screening in the past year.
Not a fit: Women who are pregnant or breastfeeding, have had a mastectomy or prior breast cancer, are outside the 35–64 age range, or had recent breast screening are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, robotic ultrasound could increase cancer detection and expand access to quality screening in rural and resource-limited settings where trained sonographers are scarce.
How similar studies have performed: Automated and operator-independent ultrasound systems have shown promise for improving detection—particularly in dense breasts—but large randomized comparisons to sonographer-led screening remain limited.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Xiantao, Hubei
- Rural health centers and community health centers — Xiantao, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Xiaoxv Yin, Doctor
- Email: yxx@hust.edu.cn
- Phone: 86+13871187781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.