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

Study Overview
=================
Brief Summary
-----------------
To evaluate and compare the sensitivity, specificity, AUC, pathology results of core needle biopsy and surgical pathology results coincidence rate, tumor staging, and DFS (disease-free survival) of US-detected nonpalpable breast cancer vs mammography-detected nonpalpable breast cancer.

Official Title
-----------------
The Diagnosis and Prognosis of Nonpalpable Breast Cancer Detected by the Ultrasound vs Mammography: a Clinical Noninferiority Trial.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18 years and over with full capacity for civil conduct; 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; Voluntarily participate in and sign the informed consent form, and be willing to accept the inspection designated by this test; The results of blood examination, coagulation examination, preoperative infection examination, and 12 lead ECG examination within 2 weeks before biopsy met the biopsy requirements; 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: Women are participating in another clinical trial of drug or medical device; Women with neuropsychiatric disorders; 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; Other subjects not suitable for X-ray examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MG+<br>the lesion could detected by mammography | Diagnostic Test: imaging<br>* perform US and mammography examination<br>|
| US+<br>the lesion could detected by breast ulrtasound | Diagnostic Test: imaging<br>* perform US and mammography examination<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitive | Proportion of corrected-detected malignant lesions by the US or MG | 3 days | 
| Specificity | Proportion of corrected-detected benign lesions by the US or MG | 3 days | 
| Area under curve | Area under receiver operating characteristic (ROC) curve in percentage (%) | 3 days | 
| Disease-free survival (DFS) | The time that the patient is free of the signs and symptoms of a disease after treatment. | 3 years |