NCT06843083

Contrast Enhanced Mammography or Breast Magnetic Resonance: Which Choice for Optimal Diagnostic Performance?

Contrast-Enhanced Mammography or Breast MRI: Which Choice for Optimal Diagnostic Performance?

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Graziella di Grezia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study compares the diagnostic performance of Contrast-Enhanced Mammography (CEM) and Breast MRI in evaluating breast lesions. It aims to assess sensitivity, specificity, and diagnostic accuracy to identify the optimal imaging modality for clinical scenarios such as dense breast tissue and high-risk populations.

Detailed description

Search differences and performance of MRI and CEM

Conditions

• Breast Cancer Prevention
• Breast Cancer Diagnosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CEM protocol	CEM combines low-energy mammography with high-energy contrast-enhanced imaging to highlight areas of neo-angiogenesis, which are indicative of malignancy. This intervention will be used to evaluate the diagnostic performance of CEM in detecting and characterizing breast lesions, especially in patients with dense breast tissue or inconclusive findings from routine mammography.
DIAGNOSTIC_TEST	breast MRI	MRI (Magnetic Resonance Imaging): MRI will be used as an alternative imaging modality for breast lesion detection and characterization. MRI provides detailed soft tissue imaging and is widely used in the evaluation of high-risk patients or those with dense breast tissue. The results from MRI will be compared to CEM findings to determine which modality offers superior diagnostic accuracy and clinical impact.

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-03-01
• Completion: 2026-01-31
• First posted: 2025-02-24
• Last updated: 2025-02-24

Locations

1 site across 1 country: Italy