Mammography
Conditions
Keywords
breast cancer, breast ultrasound, contrast enhanced mammography
Brief summary
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.
Interventions
DIAGNOSTIC_TESTContrast-Enhanced Mammography
Only patients in the prospective cohort will undergo CEM in addition to breast ultrasound.
Sponsors
ZHOU Yidong
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Breast ultrasound or/and general mammography suggest that the lesion is BI-RADS 4 or above; * Willing to undergo enhanced mammography examination; * Agree to perform tumor core needle biopsy or excisional biopsy to confirm pathological diagnosis when necessary.
Exclusion criteria
* Allergy to iodinated contrast; * Pregnant and lactating women; * Suffering from kidney disease or abnormal kidney function, or undergoing renal dialysis; * The breast is too large to be completely included in the full-field mammography examination at one time; ○5 Those with breast implants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| lesion biopsy rate | 2 years | Total biopsy rate (including core needle biopsy and lesion excision biopsy) in patients with BI-RADS 4 and above with and without CEM. |
| breast cancer detection rate | 2 years | Proportion of breast cancer detected among all patients undergoing biopsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of BI-RADS score upgrade | 3 years | number of BI-RADS score upgrade during follow-up |
Countries
China
Contacts
Primary ContactYidong Zhou, Master
Outcome results
None listed