NCT06713915

Diagnostic Performance of Contrast-Enhanced Mammography

Diagnostic Performance of Contrast-Enhanced Mammography in Suspicious Breast Lesions

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: ZHOU Yidong · Academic / Other
• Sex: Female
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mammography

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Contrast-Enhanced Mammography	Only patients in the prospective cohort will undergo CEM in addition to breast ultrasound.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-12-03
• Last updated: 2024-12-03

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study