Breast lesions
Conditions
Interventions
Gold Standard:The "gold standard" in this study is the histopathological results from needle biopsy or surgical resection. For lesions diagnosed as benign via imaging where surgery is not recommended,
Index test:The index test to be evaluated is Ultrasound Localization Microscopy (ULM). This technology performs diagnosis by acquiring quantitative micro-blood flow parameters, including vessel ratio,
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female aged >=18 years old; 2. Breast lesions detected by ultrasound; 3. Clinical decision for further evaluation or treatment; 4. No specific treatment for breast lesions (such as neoadjuvant chemotherapy, radiotherapy, etc.) within 1 month before the examination; 5. Voluntarily sign the informed consent form and cooperate to complete the research process.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating females; 2. History of hypersensitivity to ultrasound contrast agents (e.g., sulfur hexafluoride microbubbles); 3. Severe cardiac, hepatic, or renal dysfunction (LVEF 3 \times upper limit of normal, or eGFR<60 mL/min/1.73m²); 4. Active infection or other systemic diseases that may interfere with the examination results; 5. Previous surgery or radiotherapy on the ipsilateral breast; 6. Incomplete clinical, imaging, or pathological data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative morphological features of microvasculature;Quantitative hemodynamic features of the microvasculature; | — |
Countries
China
Contacts
Public ContactHansheng Xia
Zhongshan Hospital, Fudan University
Outcome results
None listed