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

The First Affiliated Hospital of the Fourth Military Medical University

Status: Unknown

Conditions: Breast Cancer

Treatments: Diagnostic Test: imaging

Study type: Observational

Funder types: Other

Identifiers

NCT04360616

US-MAM

Details and patient eligibility

About

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.

Enrollment: 1,277 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,277 participants in 2 patient groups

MG+

Description:

the lesion could detected by mammography

Treatment:

Diagnostic Test: imaging

US+

Description:

the lesion could detected by breast ulrtasound

Treatment:

Diagnostic Test: imaging