Table 1.

Inclusion criteria: Full list of the inclusion and exclusion criteria of the study

Eligibility criteria

1. Previous digital mammography and ultrasound and magnetic resonance imaging

2. Suspicious or malignant diagnosis by FNAC (C4 or C5), by core biopsy (CB) or VABB (B4 or B5)

3. Dense breast (ACR class 3 or 4 on mammography)

4. Capable and willing to comply with study procedures, having signed the informed consent form

5. Breast size compatible with the dimensions of the image detector

6. In sufficiently good health to undergo standard breast cancer care and CESM examination

Exclusion criteria

1. High risk of adverse events related to iodinated contrast agents

2. Previously included in this study

3. Participating in, or having participated in another clinical trial(s) within the 30 days precedent

4. Previous breast reconstructive surgery or breast implant(s)

5. Concomitant or previous radiotherapy to the thorax area or systemic chemotherapy

6. Proven or supposed pregnancy