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.
Search differences and performance of MRI and CEM
Study Type
OBSERVATIONAL
Enrollment
350
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 (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.
University of Campania Luigi Vanvitelli
Naples, Italy
Diagnostic Accuracy of CEM vs. MRI for Breast Lesion Detection and Characterization
The primary outcome of the study is to compare the diagnostic accuracy of Contrast-Enhanced Mammography (CEM) and Breast Magnetic Resonance Imaging (MRI) in detecting and characterizing breast lesions. This will be assessed by evaluating the sensitivity, specificity, and overall diagnostic performance of both imaging modalities. Findings will be correlated with histopathological results or follow-up imaging to determine the accuracy of each modality in the diagnosis of breast cancer.
Time frame: From enrollment to the end of treatment at 12 months
Sensitivity and Specificity of CEM vs. MRI
This secondary outcome aims to compare the sensitivity and specificity of CEM and MRI in detecting breast lesions. Sensitivity refers to the ability to correctly identify true positives, while specificity refers to correctly identifying true negatives. These metrics will be analyzed to assess the diagnostic capability of each imaging technique.
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
The positive predictive value (PPV) and negative predictive value (NPV) will be calculated for both CEM and MRI. PPV indicates the proportion of positive test results that are true positives, while NPV indicates the proportion of negative test results that are true negatives.
Time frame: From enrollment to the end of treatment at 12 months
Patient Preference and Tolerability of CEM vs. MRI
This outcome will assess patient preference and tolerability between CEM and MRI. Patients will be asked to complete a questionnaire regarding their comfort during each imaging procedure, and their preference for one modality over the other will be recorded.
Time frame: From enrollment to the end of treatment at 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.