The Diagnosis and Prognosis of Nonpalpable Breast Cancer Detected by the US vs Mammography: a Clinical Noninferiority Trial.

Inclusion Criteria:

1. Women aged 18 years and over with full capacity for civil conduct;
2. Breast imaging examination (including mammography and breast ultrasound) found that patients with BI-RADS 4 or nonpalpable lesion need to have breast biopsy (refer to the classification of BI-RADS, which is consistent with the indications for biopsy), including some patients with BI-RADS 3 nonpalpable breast lesions who are willing to have biopsy;
3. Voluntarily participate in and sign the informed consent form, and be willing to accept the inspection designated by this test;
4. The results of blood examination, coagulation examination, preoperative infection examination, and 12 lead ECG examination within 2 weeks before biopsy met the biopsy requirements;
5. It conforms to the biopsy standard (refer to the image-guided breast histology biopsy guide in the breast cancer diagnosis and treatment guide and specification of China Anti Cancer Association (2019 version)).

Exclusion Criteria:

1. Women are participating in another clinical trial of drug or medical device;
2. Women with neuropsychiatric disorders;
3. Women with severe systemic diseases and serious bleeding diseases that can not cooperate with the examination, or the researchers think it is not suitable to participate in this clinical trial;
4. Other subjects not suitable for X-ray examination