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Assessment of breast disease from bi-modal bi-view ultrasound images and text information by deep learning: a bicenter prospective cohort study

Assessment of breast disease from bi-modal bi-view ultrasound images and text information by deep learning: a bicenter prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300072061
Enrollment
Unknown
Registered
2023-06-01
Start date
2020-08-28
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Breast disease

Interventions

Index test:Breast artificial intelligence model diagnoses benign and malignant breast tumors

Sponsors

The Seventh Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1) With a clear pathology: histological biopsy or surgical resection; 2) Provide at least a bimodal ultrasound image view (B-mode/color Doppler) and complete medical history text; 3) For patients with multiple lesions, select the highest nodule of BI-RADS class. Multiple nodules in the same category, choose the largest, ensure that there is only one nodule per breast, and a maximum of two nodules per patient; 4) The lesions were classified as BI-RADS 2~5, and the positive results were selected; 5) Select solid or mostly solid lesions (cystic component<25%).

Exclusion criteria

Exclusion criteria: 1) mental illness or major underlying medical condition (e.g. tumor); 2) Implants, pregnant or lactating women; 3) Those who have undergone surgery or chemotherapy; 4) Poor image quality; 5) Patients under 18 years of age.

Design outcomes

Primary

MeasureTime frame
Area Under Curve;F1 Score;

Secondary

MeasureTime frame
Accuracy;Positive predictive value;Negative predictive value;Sensitivity;

Countries

China

Contacts

Public ContactFengping Liang

The Seventh Affiliated Hospital, Sun Yat-sen University

liangfp@mail.sysu.edu.cn+86 136 2233 0538

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026