NCT06838117

From Variability to Standardization: The Impact of Breast Density on Background Parenchymal Enhancement in Contrast-Enhanced Mammography and the Need for a Structured Reporting System

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 213 (estimated)
• Sponsor: Graziella di Grezia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This retrospective study includes 213 patients who underwent CEM, mammography (MG), and ultrasound (US) between May 2022 and June 2023 at the P.O. 'A. Perrino' Hospital, Brindisi. BPE was categorized into four levels (Minimal, Light, Moderate, and Marked), while breast density was rated according to the ACR BI-RADS (A-D) classification. A statistical analysis was performed to assess the correlation between BPE and breast density, supporting the development of the BPE-CEM Standard Scale (BCSS) to standardize reporting and improve interobserver agreement.

Conditions

• To Establish a Standardized Background Parenchimal Enhancement Classification System

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-06-30
• Completion: 2025-02-01
• First posted: 2025-02-20
• Last updated: 2025-02-21

Locations

1 site across 1 country: Italy