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

NCT06838117 | Enrolling By Invitation

• 1 other identifier: T_5_2025
• Study Type: observational
• Target: 213
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Correlation between breast density and background parenchymal enhancement (BPE) in CEM.

  This outcome assesses whether increased breast density is associated with higher BPE levels and evaluates the statistical significance of the correlation.

  Data analysis within 12 months of study completion.

Secondary Outcomes (1)

• Development and validation of the BPE-CEM Standard Scale (BCSS).

  Within 12 months of study completion.

Study Arms (1)

Retrospective Cohort of Women Undergoing Contrast-Enhanced Mammography (CEM) for Diagnostic and Surv

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 years and older who underwent CEM for diagnostic or surveillance purposes. Patients with recorded BPE levels and BI-RADS breast density classification.

You may qualify if:

• Patients who underwent CEM, mammography, and ultrasound between May 2022 and June 2023.
• Availability of BPE assessment and BI-RADS density classification.
• Complete imaging dataset available for analysis.

You may not qualify if:

• Patients with prior breast cancer treatment that could alter BPE.
• Incomplete imaging data or missing classification values.
• Contraindications to contrast-enhanced imaging.

Sponsors & Collaborators

• Graziella di Grezia: lead
• Link Campus University: collaborator
• University of Campania Luigi Vanvitelli: collaborator

Study Sites (1)

Pellino Hospital

Brindisi, Italy

Location

Study Officials

• Graziella Di Grezia, Medicine and Surgery

  Link Campus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: May 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: February 1, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)