Breast cancer
Conditions
Interventions
Gold Standard:The postoperative histopathological results of SLNB and subsequent ALND (if applicable) are taken as the gold standard for diagnosis
Index test:The combined strategy of CEUS and CEUS-CNB for diagnosing axillary lymph node metastasis
Sponsors
Meizhou People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female patients aged >=18 years; 2. Diagnosis of breast invasive carcinoma or carcinoma in situ; 3. Clinical T stage assessed by imaging as cTis-2 or ycT0-2; 4. Axillary lymph node status assessed by ultrasound as negative (cN0, ycN0), defined as regular nodal morphology, a clear hilar structure, and absence of focal or diffuse cortical thickening (cortical thickness <3 mm), or as suspicious (cN1); 5. Voluntary participation, with signed informed consent, good compliance, and willingness to cooperate with the study examinations and procedures;
Exclusion criteria
Exclusion criteria: 1. Patients with breast cancer during pregnancy or lactation; 2. Patients with distant metastases; 3. Patients with bilateral breast cancer; 4. Patients with a history of prior radiation therapy to the breast or chest region; 5. Patients with a known allergy to ultrasound contrast agents;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Negative Predictive Value (NPV) of CEUS Combined with CEUS-CNB Strategy for Diagnosing Axillary Lymph Node Metastasis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, Specificity, Positive Predictive Value (PPV), Accuracy, and Corresponding 95% Confidence Intervals (CI); | — |
Countries
China
Contacts
Public ContactLi Xiaoyuan
Meizhou People's Hospital
Outcome results
None listed