Breast lesions
Conditions
Interventions
Malignant group:None
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. The conventional ultrasound diagnosis is BI-RADS category 4, with the maximum diameter of the breast mass <=2cm, or the maximum diameter of the non-mass lesion of the breast <=5cm (ACR BI-RADS guidelines); 2. Patients underwent contrast-enhanced ultrasound examination before the operation or puncture, with no contraindications to contrast-enhanced ultrasound, and all patients provided written informed consent before contrast-enhanced ultrasound examination. 3. The patient did not undergo puncture biopsy or neoadjuvant therapy before ultrasound and contrast-enhanced ultrasound examinations. 4. The patient has pathological results of puncture biopsy or surgical resection within one month after contrast-enhanced ultrasound examination. 5. For patients with contrast-enhanced ultrasound downgraded to BI-RADS class 3, if there is no pathological result of puncture biopsy or surgical resection to confirm it, BI-RADS class 3 on DCE-MRI shall be used as the basis for diagnosis, or the inclusion of benign lesions shall be based on the fact that the size of the lesion does not change in imaging examinations such as ultrasound one year later.
Exclusion criteria
Exclusion criteria: 1.Patients who have undergone puncture biopsy or neoadjuvant chemotherapy before ultrasound examination; 2. Cases where ultrasound images were not collected in a standardized manner; 3. Patients downgraded to BI-RADS category 3 were lost to follow-up without a confirmed pathological or MRI examination. 4. Patients with malignant diagnosis grades have no final surgical or puncture results; 5. Patients who have contraindications to contrast-enhanced ultrasound examination or are unwilling to sign the informed consent form for contrast-enhanced ultrasound examination; 6. Patients whose lesions are not visible on ultrasound; 7. Patients with uncertain contrast-enhanced ultrasound examination results; 8. Patients with uncertain pathological results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The downgrade rate of biopsy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic sensitivity;Diagnostic specificity;Accuracy;Predictive performance; | — |
Countries
China
Contacts
Public ContactFan Li
Shanghai Chest Hospital
Outcome results
None listed