Breast DiseasesNCT07915050
Evaluation of Scanning and Diagnostic Performance of an Autonomous Dual-Arm Breast Ultrasound Robot
An observational study of Breast Diseases, run by Huazhong University of Science and Technology at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Diseases
- What is being tested?
- Autonomous Dual-Arm Robotic Breast Ultrasound
- How many people
- 885 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jun 2026to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Aged 18-80 years.
- No history of breast cancer.
- Willing to voluntarily participate in breast screening.
Who cannot join
- History of breast resection surgery.
- Pregnant or breastfeeding women.
- Presence of prosthetic implants.
- Women with an allergy to ultrasound coupling gel.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Taihe Hospital of Shiyan City
Shiyan, Hubei, 442000
Xiaoxv Yin, Doctor, 86+13871187781, yxx@hust.edu.cn
- Not yet recruiting
Wuhan Children's Hospital
Wuhan, Hubei, 430016
Xiaoxv Yin, 13871187781, yxx@hust.edu.cn
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology (Optical Valley Branch)
Wuhan, Hubei, 430030
Xiaoxv Yin, +86 13871187781, yxx@hust.edu.cn
- Recruiting
Xiantao First People's Hospital
Xiantao, Hubei, 433000
Xiaoxv Yin, +86 13871187781, yxx@hust.edu.cn
About this study
Official title: Evaluation of Scanning and Diagnostic Performance of an Autonomous Dual-Arm Breast Ultrasound Robot: A Prospective, Multicenter Study
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.
Read the detailed description
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.
- Conditions
- Breast Diseases
- Being tested
- Autonomous Dual-Arm Robotic Breast Ultrasound
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomous Dual-Arm Robotic Breast UltrasoundDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Breast Ultrasound Screening Cohort | Eligible participants will undergo conventional handheld breast ultrasound followed by autonomous dual-arm robotic breast ultrasound. Receives: Diagnostic Test: Autonomous Dual-Arm Robotic Breast Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between Expert BI-RADS Classifications Based on Robotic and Handheld Breast Ultrasound Images
Measured: 6 weeks after completion of image collection for all participants
Secondary outcomes (12)
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.
Measured: 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.
Measured: 6 weeks after completion of image collection for all participants
Lesion-Level Detection Sensitivity
Measured: 6 weeks after completion of image collection for all participants
Mean Number of False-Positive Lesion Detections per Breast Ultrasound Examination
Measured: 6 weeks after completion of image collection for all participants
Lesion Detection Precision
Measured: 6 weeks after completion of image collection for all participants
Proportion of Breast Lesions With Accurate Localization Based on Expert Reference Assessment
Measured: 6 weeks after completion of image collection for all participants
Agreement in Lesion Diameter Measurements
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 weeks after completion of image collection for all participants
Patient-Level Diagnostic Performance for Breast Cancer (Sensitivity, Specificity, AUC)
Measured: 6 weeks after completion of image collection for all participants
Impact of AI Assistance on Physicians' Diagnostic Performance(Sensitivity, Specificity, AUC)
Measured: 6 weeks after completion of image collection for all participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 885 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Cobot Technology Co., Ltd.
- Responsible party
- Principal investigator, Xiaoxv Yin, PhD, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915050
- Sponsor's protocol ID
- HuazhongU2026
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Scanning and Diagnostic Performance of an Autonomous Dual-Arm Breast Ultrasound Robot: A Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT07915050
- Acronym / sponsor ID
- HuazhongU2026
- Conditions
- Breast Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 885 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Wuhan Cobot Technology Co., Ltd.
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Ultrasound Screening Cohort | – | Diagnostic Test: Autonomous Dual-Arm Robotic Breast UltrasoundEligible participants will undergo conventional handheld breast ultrasound followed by autonomous dual-arm robotic breast ultrasound. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Aged 18-80 years.
- No history of breast cancer.
- Willing to voluntarily participate in breast screening.
Key exclusion criteria (4 listed)
- History of breast resection surgery.
- Pregnant or breastfeeding women.
- Presence of prosthetic implants.
- Women with an allergy to ultrasound coupling gel.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autonomous Dual-Arm Robotic Breast UltrasoundParticipants 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. | Diagnostic test | Breast Ultrasound Screening Cohort |
Primary outcome
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
12 secondary outcomes
Proportion of Examinations With Complete Breast Coverage Assessed by Expert Review of Ultrasound Recordings
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Diseases, run by Huazhong University of Science and Technology at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoxv Yin (+8613871187781, yxx@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.