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| Name | Class |
|---|---|
| Link Campus University | OTHER |
| University of Campania Luigi Vanvitelli | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEM protocol | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 12 months |
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Inclusion Criteria:
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:
Severe Renal Impairment: Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²), as they may not safely undergo contrast-enhanced imaging.
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The study population will consist of adult women aged 18 years or older who are referred for advanced breast imaging due to suspicious breast lesions or high-risk factors for breast cancer. The population will include individuals with dense breast tissue or those who have had inconclusive findings from standard mammography, making them candidates for Contrast-Enhanced Mammography (CEM) or Breast Magnetic Resonance Imaging (MRI).
The study aims to include a diverse cohort of patients, both in terms of age and background, as long as they meet the inclusion criteria and do not fall under the exclusion criteria. The study will be conducted at ASL Avellino, Italy, and will involve patients from various risk groups, including those with a family history of breast cancer, personal history of other cancers, and those with dense breast tissue who may require advanced imaging for accurate diagnosis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Campania Luigi Vanvitelli | Naples | 80138 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| breast MRI | 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. |
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| 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. | 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. | From enrollment to the end of treatment at 12 months |
| D017437 |
| Skin and Connective Tissue Diseases |