Research on the Whole-Process Intelligent Diagnosis and Treatment of Digital Breast Tomosynthesis Based on Deep Learning: Multicenter Retrospective and Prospective Validation
Sponsor: Yunnan Cancer Hospital
Trial Details
| Condition | Breast Carcinoma |
| Intervention | To explore the value of digital breast tomosynthesis based on deep learning in the diagnosis of breast cancer |
| Phase | NA |
| Status | Not_yet_recruiting |
| Participants | 5,000 |
| Est. Completion | 31 Dec 2026 |
| Last Updated | 22 May 2026 |
Primary Outcome
The accuracy of the multi-task deep learning-based intelligent diagnostic model in differentiating benign and malignant breast lesions on digital breast tomosynthesis (DBT) images.
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria 1. Female patients aged ≥ 18 years. 2. Complete bilateral digital breast tomosynthesis (DBT) images available, including craniocaudal (CC) and mediolateral oblique (MLO) views. 3. Confirmed pathological diagnosis (core needle biopsy or surgical resection) serving as the reference standard; or benign lesions with stable findings on follow-up for more than 2 years. 4. (For the efficacy prediction subgroup) Patients who received complete neoadjuvant therapy and had postoperative pathological results. 2\. Exclusion Criteria 1. Poor image quality with severe artifacts that precluded reliable analysis. 2. History of previous breast surgery or radiotherapy (except for the recurrence risk subgroup). 3. Incomplete clinical or pathological data.
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