early-stage breast cancer
Conditions
Interventions
Gold Standard:Paraffin-embedded histopathology findings of postoperative axillary lymph nodes
Index test:Clinical features, MR features, whole-slide pathology features
Sponsors
Jiangmen Central Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Prospective: 1. Female patients aged >= 18 years who have signed an informed consent form;Pathology confirmed as unilateral breast cancer following biopsy; 2.Axillary lymph nodes clinically negative or clinically abnormal but negative on needle biopsy; 3.Standardized multiparametric breast MRI completed at this institution within 7 days prior to surgery; 4.Planned to proceed directly to breast surgery after biopsy without any neoadjuvant therapy (including chemotherapy, radiotherapy, endocrine therapy, or ablation therapy); 5.Intraoperative axillary sentinel lymph node biopsy ± axillary lymph node dissection planned; 6.Sufficient biopsy tissue available for whole-slide scanning analysis; 7.Complete clinical and pathological data available for subsequent analysis; Retrospective: 8.Patients pathologically confirmed with invasive breast cancer between January 1, 2019 and August 31, 2025; 9.Underwent multiparametric breast MRI within 3 weeks prior to breast surgery; 10. Did not receive any anti-tumor treatment before biopsy or MRI examination; 11.Clinically node-negative axilla, or clinically abnormal axilla but negative fine-needle aspiration/core needle biopsy; 12.Underwent axillary sentinel lymph node biopsy (SLNB) or SLNB combined with axillary lymph node dissection (ALND).
Exclusion criteria
Exclusion criteria: Prospective: 1.History of breast cancer in the same or opposite breast, or prior breast/axillary surgery; 2.Pregnant or lactating women;Bilateral or multifocal breast cancer; 3.Presence of other malignancies; 4.Allergy to MRI contrast agents or contraindications for MRI (e.g., metallic implants, pacemakers, severe claustrophobia, renal insufficiency, etc.); 5.Imaging studies suggest distant metastasis; 6.Patients scheduled to undergo neoadjuvant chemotherapy, radiotherapy, endocrine therapy, or ablation therapy; 7.Patients unable to complete the study or with poor compliance; 8.Patients with poor MRI image quality or regions of interest (ROI) that are too small for effective analysis; 9.Non-lump breast cancer; Retrospective: 10. History of primary breast cancer or axillary surgery prior to imaging acquisition; 11.Bilateral or multifocal breast cancer; 12.Severe MRI artifacts, missing imaging sequences, or effective ROI voxel count < 64; 13.Insufficient biopsy tissue; 14. Non-mass-like breast cancer; 15.Presence of distant metastasis; 16. Incomplete clinicopathological data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Status of sentinel lymph node metastasis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Status of non-sentinel lymph node metastasis; | — |
Countries
China
Contacts
Public ContactQunchen Zhang
Jiangmen Central Hospital
Outcome results
None listed