Benign breast nodule
Conditions
Interventions
Index test:Diagnostic results from AI breast ultrasound screening software
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75, female (male breast cancer cases are rare, can be included at discretion but must be marked separately); 2. Need to undergo breast ultrasound (dynamic scanning and static image capture), examination site is both breasts; 3. After the exam, should be able to obtain complete dynamic ultrasound images (continuous scan video) and static ultrasound images (at least 3 key planes: transverse, longitudinal, and oblique), meeting AI software analysis requirements; 4. Willing to participate in this study, sign informed consent, and able to cooperate with follow-up and gold standard verification; 5. No severe liver or kidney dysfunction, mental illness, coagulation disorders, or other basic diseases that may affect the study; 6. Have not participated in other similar breast AI-related clinical studies.
Exclusion criteria
Exclusion criteria: 1. Poor quality of breast ultrasound images (blurry, severe artifacts, incomplete sections), which cannot meet the AI software analysis requirements; 2. History of breast surgery, radiotherapy/chemotherapy, or breast implant, affecting ultrasound image interpretation; 3. Already diagnosed with breast cancer and has received surgery, radiotherapy, chemotherapy, or other treatments; 4. Pregnant or breastfeeding women (breast tissue congestion and edema affecting imaging features); 5. Refuses to sign the informed consent form or cannot cooperate with follow-up or gold-standard verification; 6. Has other malignant tumors, with an expected survival of less than 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of identifying breast tumors, benign or malignant; | — |
Secondary
| Measure | Time frame |
|---|---|
| the independent diagnostic results of ultrasound physicians with different professional titles/levels (junior, intermediate, and senior) versus the real-time on-device analysis results of the AI sof;examination and diagnostic time, System Usability Scale (SUS) scores for the AI software, and compatibility/operational records on GE ultrasound equipment.; | — |
Countries
China
Contacts
Public ContactSun Desheng
Peking University Shenzhen Hospital
Outcome results
None listed