Diagnostic Performance of Contrast-Enhanced Mammography

ZHOU Yidong

Status: Not yet enrolling

Conditions: Mammography

Treatments: Diagnostic Test: Contrast-Enhanced Mammography

Study type: Observational

Funder types: Other

Identifiers

NCT06713915

PUMCH-breast-CEM

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 2 patient groups

prospective cohort

Description:

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.

Treatment:

Diagnostic Test: Contrast-Enhanced Mammography

retrospective cohort

Description:

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.