Breast Cancer Diagnosis, Breast Cancer Detection
Conditions
Keywords
Second look ultrasound, contrast enhanced mammography, breast cancer detection
Brief summary
This study investigates the utility of second-look ultrasound (US) following contrast-enhanced mammography (CEM) to characterize additional lesions detected during routine breast imaging.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTCEM protocol
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.
Sponsors
Link Campus University
University of Campania Luigi Vanvitelli
Graziella di Grezia
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing contrast-enhanced mammography for diagnostic or surveillance purposes. * Identification of additional lesions on CEM requiring further evaluation. * Ability to provide informed consent.
Exclusion criteria
* Known breast cancer diagnosis without suspicion of additional lesions. * Contraindications to ultrasound or contrast agents. * Patients with incomplete imaging data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection Rate of Additional Lesions on CEM | Within 12 months of imaging assessment. | This measure evaluates the number of additional lesions identified on Contrast-Enhanced Mammography (CEM) that require further assessment through second-look ultrasound or biopsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance Between Imaging Findings and Histopathology | Up to 3 months post-biopsy. | This measure assesses the percentage of biopsied lesions in which imaging findings (from CEM and SLUS) correlate with the histopathological results |
| Concordance Between Imaging Findings and Follow-Up Imaging | 6-12 months after the initial CEM examination | 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. |
Countries
Italy
Outcome results
None listed