BI-RADS diagnosis in breast patients using artificial intelligence: a practical randomized cross controlled trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300073777

Enrollment

Unknown

Registered

2023-07-20

Start date

2022-08-01

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast nodule

Interventions

group A:Stage 1: Breast ultrasound BI-RADS diagnosis was performed on all 1000 sample images without the prompt of the intelligent breast system, and the results given by the doctor were recorded. Sta

group B:The first stage: Breast ultrasound BI-RADS diagnosis was performed on data b (500 images) without the prompt of the intelligent breast system, and the results given by the doctor were recorded

Eligibility

Sex/Gender

Female

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Female aged =18 years; 2) Color ultrasound examination of breast is planned;

Exclusion criteria

Exclusion criteria: Participant exclusion criteria: 1) Age < 18 years old; 2) History of breast plastic surgery, inflammation, chemoradiotherapy, breast cancer surgery and other breast surgery; 3) Pregnant or lactating women; Ultrasonic image exclusion criteria: 1) Breast ultrasound images deviate from standard image acquisition standards; 2) Ultrasound images of axillary lymph nodes; 3) No ultrasound images of the breast area;

Design outcomes

Primary

Measure	Time frame
accuracy;	—

Secondary

Measure	Time frame
specificity;sensitivity;precision; F1-score;	—

Countries

China

Contacts

Public ContactFanxin Zeng

Dazhou Central Hospital

zengfx@pku.edu.cn+86 173 2332 0678

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026