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ENROLLING BY INVITATION
NCT06843083

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

Sponsor: Graziella di Grezia

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

350

Start Date

2025-02-01

Completion Date

2026-01-31

Last Updated

2025-02-24

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

University of Campania Luigi Vanvitelli

Naples, Italy