Contrast Enhanced Mammography or Breast Magnetic Resonance: Which Choice for Optimal Diagnostic Performance?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CEM protocol, breast MRI.
- Who it may be relevant to
- Registry conditions: Breast Cancer Prevention, Breast Cancer Diagnosis. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Contrast-Enhanced Mammography or Breast MRI: Which Choice for Optimal Diagnostic Performance?
Overview
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
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.
Primary outcome measures
- Diagnostic Accuracy of CEM vs. MRI for Breast Lesion Detection and Characterization [Time frame: From enrollment to the end of treatment at 12 months]
Secondary outcome measures (3)
- Sensitivity and Specificity of CEM vs. MRI [Time frame: From enrollment to the end of treatment at 12 months]
- Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of CEM vs. MRI [Time frame: From enrollment to the end of treatment at 12 months]
- Patient Preference and Tolerability of CEM vs. MRI [Time frame: From enrollment to the end of treatment at 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- University of Campania Luigi Vanvitelli — Naples
Identifiers
NCT: NCT06843083 · T_2_2025