Robotic versus sonographer breast ultrasound screening
Official title: Evaluation of the Effect of Using Ultrasound Robots for Breast Cancer Screening: A Multicenter, Parallel-group, Cluster Randomized Controlled Trial
Run by Huazhong University of Science and Technology · NCT07331363 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 35 Years to 64 Years |
| Sex | Women only |
| Enrollment | 70000 (estimated) |
| Sponsor | Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Xiantao, Hubei) |
| Status | Recruiting |
| Started | December 10, 2025 |
| Main results expected | December 10, 2026 |
| Study ends | December 10, 2026 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07331363 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.