Diagnostic Performance of Contrast-Enhanced Mammography

N/ANot Yet RecruitingNCT06713915

ZHOU Yidong600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Mammography

Interventions

Contrast-Enhanced MammographyDIAGNOSTIC_TEST

Only patients in the prospective cohort will undergo CEM in addition to breast ultrasound.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 2 years

breast cancer detection rate

Proportion of breast cancer detected among all patients undergoing biopsy.

Time frame: 2 years

Secondary Outcomes

number of BI-RADS score upgrade

number of BI-RADS score upgrade during follow-up

Time frame: 3 years