Non-inferiority Study of Contrast-enhanced Digital Mammography (CEDM) vs Magnetic Resonance Imaging (MRI) in Terms of Diagnostic Accuracy in Patients Undergoing Preoperative Staging of Established Invasive Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30+
SponsorAzienda Ospedaliera Universitaria Integrata Verona

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • breast-MRI and CEM

Treatment groups

216 Participants
are divided into 1 treatment group

Sponsors and collaborators