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| Name | Class |
|---|---|
| Link Campus University | OTHER |
| University of Campania Luigi Vanvitelli | OTHER |
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This study investigates the utility of second-look ultrasound (US) following contrast-enhanced mammography (CEM) to characterize additional lesions detected during routine breast imaging.
The goal is to assess the diagnostic accuracy and clinical value of combining CEM with targeted ultrasound to improve lesion characterization and guide biopsy decisions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEM protocol | Diagnostic Test | The intervention consists of Second-Look Ultrasound (SLUS) performed following Contrast-Enhanced Mammography (CEM) to further evaluate additional lesions detected during routine breast imaging. When CEM identifies additional or suspicious lesions not clearly characterized by mammography alone, targeted ultrasound is conducted to assess lesion morphology, vascularity, and acoustic characteristics. Radiologists with expertise in both CEM and ultrasound interpretation will perform SLUS to determine whether the lesions require biopsy, short-term follow-up, or no further action. Findings will be correlated with histopathological results (if biopsy is performed) or follow-up imaging to assess diagnostic accuracy. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection Rate of Additional Lesions on CEM | This measure evaluates the number of additional lesions identified on Contrast-Enhanced Mammography (CEM) that require further assessment through second-look ultrasound or biopsy. | Within 12 months of imaging assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance Between Imaging Findings and Histopathology | This measure assesses the percentage of biopsied lesions in which imaging findings (from CEM and SLUS) correlate with the histopathological results | Up to 3 months post-biopsy. |
| Concordance Between Imaging Findings and Follow-Up Imaging |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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Women aged 18 years and older undergoing CEM as part of diagnostic or surveillance protocols.
Lesions detected by CEM that require additional characterization.
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| Name | Affiliation | Role |
|---|---|---|
| Graziella Di Grezia, Medicine | Link Campus University | Principal Investigator |
| 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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This measure evaluates the percentage of lesions that remain stable or resolve in follow-up imaging, confirming or refuting the initial CEM and ultrasound findings. |
| 6-12 months after the initial CEM examination |
| D017437 |
| Skin and Connective Tissue Diseases |