Autonomous Dual-Arm Breast Ultrasound: Scanning Performance and Diagnostic Agreement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, non-randomized study where each participant receives both autonomous robotic and conventional handheld breast ultrasound. Two senior ultrasound experts review images from both methods in a blinded fashion to compare lesion detection, localization, measurements, and BI-RADS categorization. The study will report agreement between the two modalities on BI-RADS assessments, image quality, and lesion measurements, along with patient experience and preliminary diagnostic performance metrics. The robotic system’s AI-assisted diagnostics will also be explored for its impact on clinicians’ accuracy. This work is for research purposes only and will not guide clinical management decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18-80 years.
2. No history of breast cancer.
3. Willing to voluntarily participate in breast screening.

Exclusion Criteria:

1. History of breast resection surgery.
2. Pregnant or breastfeeding women.
3. Presence of prosthetic implants.
4. Women with an allergy to ultrasound coupling gel.

Where it's running

• Taihe Hospital of Shiyan City
  Shiyan, Hubei, China Recruiting
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology (Optical Valley Branch)
  Wuhan, Hubei, China Recruiting
• Xiantao First People's Hospital
  Xiantao, Hubei, China Recruiting
• Wuhan Children's Hospital
  Wuhan, Hubei, China Not yet recruiting

Study contacts

• Study coordinator: Xiaoxv Yin
• Email: yxx@hust.edu.cn
• Phone: +8613871187781

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.