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Clinical Trials in Italy / NCT06838117
Enrolling by invitation Observational

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 · tracked via the Priya Life Science Italy tracker
Sponsor
Graziella di Grezia
Phase
Observational
Started
2022-05-01
Last updated
2025-02-21

Condition(s) studied

To Establish a Standardized Background Parenchimal Enhancement Classification System

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 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. Exclusion Criteria: Patients with prior breast cancer treatment that could alter BPE. Incomplete imaging data or missing classification values. Contraindications to contrast-enhanced imaging.

Primary outcome measure(s)

  • Correlation between breast density and background parenchymal enhancement (BPE) in CEM. — Data analysis within 12 months of study completion.
    This outcome assesses whether increased breast density is associated with higher BPE levels and evaluates the statistical significance of the correlation.

Trial sites (1)

FacilityCityRegionStatus
Pellino Hospital Brindisi Italy

More Graziella di Grezia trials in Italy

Contrast Enhanced Mammography or Breast Magnetic Resonance: Which Choice for Optimal Diagnostic Performance? Enrolling by invitation
Contrast Enhanced Mammography in the Evaluation of Cancer of Unknown Primary Syndrome Enrolling by invitation
DWI Breast MRI in Dense Breast: A Clinical Trial to Assess the Efficacy and Diagnostic Accuracy of Diffusion Weighted Imaging in Dense Breast Tissue Enrolling by invitation
Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06838117 on ClinicalTrials.gov ↗ ← All trials in Italy