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

NCT06843083 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2025-02-24

No results posted yet for this study

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.

Conditions

  • Breast Cancer Prevention
  • Breast Cancer Diagnosis

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.

Sponsors & Collaborators

  • Link Campus University

    collaborator OTHER

  • University of Campania Luigi Vanvitelli

    collaborator OTHER

  • Graziella di Grezia

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-03-01
Completion
2026-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06843083 on ClinicalTrials.gov