The general objective of the study is to verify the diagnostic accuracy of contrast-enhanced mammography (CEM) compared to breast magnetic resonance imaging in patients undergoing preoperative staging for breast neoformations that have already been diagnosed and in patients undergoing neoadjuvant chemotherapy.
In addition to performing a preoperative breast resonance imaging, which is always performed in these patients, one contrast-enhanced mammography per patient is planned.
In patients undergoing neoadjuvant chemotherapy, which usually undergo MRI examination at the beginning, mid-cycle and at the end of chemotherapy treatment, a CEM will also be acquired same way at the beginning, mid-cycle and at the end of chemotherapy treatment.
The study requires, for the execution of the contrast-enhanced mammography exam, the administration of an iodinated contrast medium that is completely analogous to that used in computed tomography.
women in pre-hospitalization with already established invasive breast cancer (T1-2)
over the age of 30
with BI-RADS mammography pattern> 1
Written and signed informed consent for research
women with breast implants
women under the age of 30
Any contraindication to performing the MRI exam
Women with known BRCA 1 and BRCA 2 mutation
Single group
breast-MRI and CEM
Other interventionParticipants will undergo a breast MRI followed by CEM for local breast cancer staging
Diagnostic accuracy of the CEDM against breast MRI
The primary outcome is to assess diagnostic accuracy (including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)) of CEDM versus MRI, using histopathology as the gold standard. A non-inferiority margin (Δ) of 15% is defined. The non-inferiority hypothesis will be tested using paired binary outcomes, and sample size calculations for groups 1 and 2 follow the Liu et al. method, accounting for dependent diagnostic testing.
Inter-observer agreement
Assessment of interobserver agreement between radiologists interpreting CEDM using Cohen's kappa for categorical assessments and ICC for continuous variables (e.g., lesion size). Unit of Measure: Agreement coefficients (kappa, ICC)
Tumor size and regression evaluation (neoadjuvant patients)
Comparison of lesion size estimation and tumor regression in neoadjuvant chemotherapy patients at baseline (T0), 3 months (T3), and 6 months (T6). Unit of Measure: Lesion size in millimeters (mm); tumor regression in percentage (%)
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Azienda Ospedaliera Universitaria Integrata Verona
Lead sponsor
GE Healthcare
Collaborator
