An observational study in Breast Diseases, sponsored by Huazhong University of Science and Technology. Recruiting at 4 sites in China. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Huazhong University of Science and Technology · Observational
This prospective, multicenter, intraindividual paired study aims to evaluate the autonomous scanning performance of a dual-arm robotic breast ultrasound system and the diagnostic performance of the images it acquires, in comparison with conventional handheld ultrasound. The study primarily focuses on the agreement between diagnostic assessments based on images obtained using the two examination methods, while also evaluating image quality, lesion detection, and measurement performance. The robotic ultrasound findings will be collected for research purposes only and will not be used to guide clinical management; all clinical decisions will be based on routine clinical assessment.
This is a prospective, multicenter, non-randomized, intraindividual paired clinical study. All eligible participants will undergo both autonomous breast ultrasound scanning using a dual-arm robotic ultrasound system and conventional handheld ultrasound examinations, with complete ultrasound images and videos retained for both examinations. Two senior ultrasound experts will independently review images from both modalities in a blinded manner, assessing lesion detection, localization, long and short diameters, sonographic features, and Breast Imaging Reporting and Data System (BI-RADS) categories. Disagreements will be resolved by a third expert.
The primary outcome is the agreement between expert BI-RADS assessments based on robotic ultrasound images and those based on conventional handheld ultrasound images. Secondary outcomes include imaging completeness and quality, lesion detection and localization, agreement in lesion size measurements, and patient-reported examination experiences. Additionally, the study will explore the patient-level diagnostic sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of both examination methods for breast cancer detection, as well as the impact of the robotic ultrasound AI-assisted diagnostic system on physicians' diagnostic performance.
148 studies on the registry are indexed under Breast Diseases; 26 are open to participants now.
This study's planned enrollment of 885 is above the median of 213 across 50 observational studies indexed under Breast Diseases.
Browse Breast Diseases studies →Huazhong University of Science and Technology is the lead sponsor of 247 studies on the registry; 62 are open to participants now.
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Participants will be recruited from the breast ultrasound outpatient clinics of three participating hospitals in Hubei Province, China. The study population will consist of adults aged 18-80 years with no history of breast cancer who voluntarily participate in breast ultrasound screening. All eligible participants will undergo conventional handheld breast ultrasound followed by autonomous dual-arm robotic breast ultrasound.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Eligible participants will undergo conventional handheld breast ultrasound followed by autonomous dual-arm robotic breast ultrasound.
Diagnostic Test: Autonomous Dual-Arm Robotic Breast Ultrasound
Participants will undergo autonomous dual-arm robotic breast ultrasound after conventional handheld ultrasound. The system will autonomously perform breast scanning and acquire ultrasound images for subsequent evaluation of imaging and diagnostic performance. The robotic ultrasound results will not be used to guide clinical management.
Agreement Between Expert BI-RADS Classifications Based on Robotic and Handheld Breast Ultrasound Images
Time frame: 6 weeks after completion of image collection for all participants
Proportion of Examinations With Complete Breast Coverage Assessed by Expert Review of Ultrasound Recordings
Breast scanning completeness will be assessed through expert review of the complete ultrasound recordings obtained using robotic and handheld ultrasound. Each examination will be classified as complete or incomplete (Yes/No) according to whether the predefined breast scanning regions are adequately covered. The outcome will be reported as the percentage of complete examinations for each modality.
Time frame: 6 weeks after completion of image collection for all participants
Overall Breast Ultrasound Image Quality Assessed Using a 5-Point Expert Rating Scale
Overall image quality will be evaluated by experienced breast ultrasound experts using a 5-point ordinal rating scale (1 = poorest quality; 5 = best quality) based on the complete ultrasound recordings acquired using each modality.
Time frame: 6 weeks after completion of image collection for all participants
Lesion-Level Detection Sensitivity
Time frame: 6 weeks after completion of image collection for all participants
Mean Number of False-Positive Lesion Detections per Breast Ultrasound Examination
Time frame: 6 weeks after completion of image collection for all participants
Lesion Detection Precision
Time frame: 6 weeks after completion of image collection for all participants
Proportion of Breast Lesions With Accurate Localization Based on Expert Reference Assessment
Time frame: 6 weeks after completion of image collection for all participants
Agreement in Lesion Diameter Measurements
Time frame: 6 weeks after completion of image collection for all participants
Agreement Between Robotic and Handheld Ultrasound in Sonographic Features (Shape, Orientation, Margin, Echogenicity, and Posterior Acoustic Features) of Breast Lesions
Time frame: 6 weeks after completion of image collection for all participants
Patient-Reported Overall Satisfaction Score Using a 5-Point Questionnaire
Responses will be coded on a 5-point ordinal scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied. Higher scores indicate greater satisfaction.
Time frame: 6 weeks after completion of image collection for all participants
Patient-Reported Pain, Probe Pressure, and Anxiety Scores Assessed Using a 5-Point Questionnaire
Each item will be coded on a 5-point ordinal scale, ranging from 1 (none) to 5 (very pronounced). Higher scores indicate greater perceived pressure, pain, or anxiety.
Time frame: 6 weeks after completion of image collection for all participants
Patient-Level Diagnostic Performance for Breast Cancer (Sensitivity, Specificity, AUC)
Time frame: 6 weeks after completion of image collection for all participants
Impact of AI Assistance on Physicians' Diagnostic Performance(Sensitivity, Specificity, AUC)
Time frame: 6 weeks after completion of image collection for all participants
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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