Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Contrast-Enhanced Mammography (CEM) is a functional breast imaging technology. Like magnetic resonance imaging (MRI), CEM neovascularization enhancement can improve cancer detection rates, while lack of enhancement may lead to benign determination. The advantages of CEM are dramatically apparent in women with dense breasts. The purpose of this study was to investigate the additional diagnostic value of CEM added to the standard practice of mammography plus ultrasonography(US) in patients with suspicious breast lesions.
This study was a single-center prospective-retrospective combined observational study. In the prospective part, women with suspected breast abnormalities undergo prospective CEM evaluation, including acquisition of low energy (LE) images and recombined images (RI) showing enhancement, concurrently with breast US. The retrospective part selected the mammography and breast US data of female patients with suspected breast abnormalities who had previous baseline matching.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prospective cohort | Women with suspected breast abnormalities in prospective cohort will be prospectively evaluated with CEM, including acquisition of low-energy (LE) images and reconstructed images (RI) showing enhancement, concurrently with breast ultrasound (US) evaluation. |
| |
| retrospective cohort | The retrospective cohort will select the mammography and breast US data (BI-RADS score) of female patients with suspected breast abnormalities who had previous baseline matching. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-Enhanced Mammography | Diagnostic Test | Only patients in the prospective cohort will undergo CEM in addition to breast ultrasound. |
|
| Measure | Description | Time Frame |
|---|---|---|
| lesion biopsy rate | Total biopsy rate (including core needle biopsy and lesion excision biopsy) in patients with BI-RADS 4 and above with and without CEM. | 2 years |
| breast cancer detection rate | Proportion of breast cancer detected among all patients undergoing biopsy. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| number of BI-RADS score upgrade | number of BI-RADS score upgrade during follow-up | 3 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with breast lesions BI-RADS 4 and above treated at the Breast Surgery Department of Peking Union Medical College Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yidong Zhou, Master | Contact | +86-10-69158720 | zhouyd@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yanna Zhang, M.D | Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Breast Surgery,Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |