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

NCT ID: NCT06843083

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-01-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

CEM Group

CEM Group:

Patients in this group will undergo Contrast-Enhanced Mammography (CEM) as part of their diagnostic imaging workup for breast lesions. The CEM procedure will be used to evaluate the sensitivity and specificity of this imaging technique in detecting and characterizing breast lesions in patients with dense breast tissue or inconclusive findings from standard mammography.

CEM protocol

Intervention Type: DIAGNOSTIC_TEST

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.

MRI Group

MRI Group:

Patients in this group will undergo Breast Magnetic Resonance Imaging (MRI), which will be used to evaluate the diagnostic accuracy of MRI in detecting and characterizing breast lesions. The MRI procedure will be compared with CEM to assess the differences in diagnostic performance, sensitivity, specificity, and clinical impact in managing patients with high-risk factors or dense breast tissue.

breast MRI

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

CEM

Eligibility Criteria

Inclusion Criteria

• Age: Women aged 18 years and older.
• Indication for Advanced Imaging: Patients referred for Contrast-Enhanced Mammography (CEM) or Breast MRI due to suspicious findings or high-risk factors for breast cancer.
• Dense Breast Tissue or Inconclusive Findings: Patients with dense breast tissue or inconclusive results from standard mammography.

Informed Consent: Ability to provide written informed consent for participation in the study.

• Presence of Breast Tissue: Female or transgender women who have breast tissue suitable for imaging.

Exclusion Criteria

• Contraindications to MRI: Patients with contraindications to Breast MRI (e.g., implanted pacemakers, severe claustrophobia, or metallic implants that cannot be removed).
• Contraindications to Contrast Agents: Patients who have allergies or contraindications to iodinated contrast agents used in CEM.

Severe Renal Impairment: Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²), as they may not safely undergo contrast-enhanced imaging.

• Pregnancy or Breastfeeding: Women who are pregnant or breastfeeding, as the use of contrast agents may pose risks to the fetus or infant.
• Already Confirmed Primary Tumor: Patients with a confirmed primary breast malignancy or another primary tumor site (e.g., gastrointestinal, lung) that has already been diagnosed.
• Other Medical Conditions: Patients with serious medical conditions that may interfere with participation in the study or may affect the safety of the imaging procedures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Link Campus University

OTHER

Sponsor Role: collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: collaborator

Graziella di Grezia

OTHER

Sponsor Role: lead

Responsible Party

Graziella di Grezia

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Campania Luigi Vanvitelli

Naples, , Italy

Countries

Italy

Other Identifiers

T_2_2025

Identifier Type: -

Identifier Source: org_study_id