Breast neoplasms
Conditions
Interventions
Gold Standard:Pathological diagnosis
Index test:Deep Learning-Based AI Analysis System for Breast Ultrasound Imaging
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Retrospective Development Stage: 1. Patients with breast tumors who underwent surgical treatment at our hospital (and cooperative centers) from January 1, 2020, to December 31, 2025; 2. Complete archived preoperative breast ultrasound images are available; 3. Clear postoperative pathological diagnosis reports are available. Prospective Validation Stage: 1. Newly diagnosed patients with breast tumors scheduled to undergo surgical treatment at our hospital starting from May 5, 2026; 2. Patients who agree to participate in this study and have signed the informed consent form; 3. Patients who will receive preoperative breast ultrasound examination according to routine clinical practice.
Exclusion criteria
Exclusion criteria: Retrospective Development Stage: 1. Patients who received neoadjuvant therapy (chemotherapy, targeted therapy, etc.) preoperatively, which may significantly alter the ultrasonic characteristics of tumors; 2. Patients with poor ultrasound image quality, missing key sections, or severe artifacts that severely affect image analysis; 3. Patients with unclear pathological diagnosis, incomplete reports, or inability to accurately match with imaging findings. Prospective Validation Stage: 1. Patients scheduled to undergo surgery after neoadjuvant therapy; 2. Patients with other severe diseases who are expected to be unable to complete surgical treatment or follow-up; 3 .Patients unable to cooperate in completing ultrasound examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;AUC; | — |
Countries
China
Contacts
Public ContactShan Dandan
Shanghai Tenth People's Hospital
Outcome results
None listed