Evaluation of Scanning and Diagnostic Performance of an Autonomous Dual-Arm Breast Ultrasound Robot
NCT07915050, Recruiting, Huazhong University of Science and Technology
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evaluation of Scanning and Diagnostic Performance of an Autonomous Dual-Arm Breast Ultrasound Robot | ClinicalTrials.gov |
| NCT number | NCT07915050 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 885 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Huazhong University of Science and Technology | ClinicalTrials.gov |
| Conditions | Breast Diseases | ClinicalTrials.gov |
| Interventions | Autonomous Dual-Arm Robotic Breast Ultrasound | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Agreement Between Expert BI-RADS Classifications Based on Robotic and Handheld Breast Ultrasound Images | 6 weeks after completion of image collection for all participants | ClinicalTrials.gov | |
| Secondary | Proportion of Examinations With Complete Breast Coverage Assessed by Expert Review of Ultrasound Recordings | 6 weeks after completion of image collection for all participants | 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. | ClinicalTrials.gov |
| Secondary | Overall Breast Ultrasound Image Quality Assessed Using a 5-Point Expert Rating Scale | 6 weeks after completion of image collection for all participants | 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. | ClinicalTrials.gov |
| Secondary | Lesion-Level Detection Sensitivity | 6 weeks after completion of image collection for all participants | ClinicalTrials.gov | |
| Secondary | Mean Number of False-Positive Lesion Detections per Breast Ultrasound Examination | 6 weeks after completion of image collection for all participants | ClinicalTrials.gov | |
| Secondary | Lesion Detection Precision | 6 weeks after completion of image collection for all participants | ClinicalTrials.gov | |
| Secondary | Proportion of Breast Lesions With Accurate Localization Based on Expert Reference Assessment | 6 weeks after completion of image collection for all participants | ClinicalTrials.gov | |
| Secondary | Agreement in Lesion Diameter Measurements | 6 weeks after completion of image collection for all participants | ClinicalTrials.gov | |
| Secondary | Agreement Between Robotic and Handheld Ultrasound in Sonographic Features (Shape, Orientation, Margin, Echogenicity, and Posterior Acoustic Features) of Breast Lesions | 6 weeks after completion of image collection for all participants | ClinicalTrials.gov | |
| Secondary | Patient-Reported Overall Satisfaction Score Using a 5-Point Questionnaire | 6 weeks after completion of image collection for all participants | 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. | ClinicalTrials.gov |
| Secondary | Patient-Reported Pain Score Assessed Using a Study-Specific 5-Point Scale | 6 weeks after completion of image collection for all participants | 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. | ClinicalTrials.gov |
| Secondary | Patient-Reported Anxiety Score Assessed Using a Study-Specific 5-Point Scale | 6 weeks after completion of image collection for all participants | 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. | ClinicalTrials.gov |
| Secondary | Patient-Reported Probe Pressure Score Assessed Using a Study-Specific 5-Point Scale | 6 weeks after completion of image collection for all participants | 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. | ClinicalTrials.gov |
| Secondary | Patient-Level Sensitivity for Breast Cancer Detection | 6 weeks after completion of image collection for all participants | ClinicalTrials.gov | |
| Secondary | Patient-Level Specificity for Breast Cancer Detection | 6 weeks after completion of image collection for all participants | ClinicalTrials.gov | |
| Secondary | Area Under the Receiver Operating Characteristic Curve (AUC) for Patient-Level Breast Cancer Detection | 6 weeks after completion of image collection for all participants | ClinicalTrials.gov | |
| Secondary | Change in Patient-Level Sensitivity With Versus Without AI Assistance (Percentage Points) | 6 weeks after completion of image collection for all participants | ClinicalTrials.gov | |
| Secondary | Change in Patient-Level Specificity With Versus Without AI Assistance (Percentage Points) | 6 weeks after completion of image collection for all participants | ClinicalTrials.gov | |
| Secondary | Change in Area Under the Receiver Operating Characteristic Curve (AUC) With Versus Without AI Assistance | 6 weeks after completion of image collection for all participants | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)