The purpose of this pilot study is to compare radiologist confidence level in evaluating patients with known breast lesions between contrast enhanced digital breast tomosynthesis (CE- DBT) and contrast enhanced dynamic magnetic resonance imaging (CE-MRI) acquired as a part of a standard clinical workup.

This is a pilot study of CE-DBT scans to evaluate its utility relative to breast CE-MRI. Twenty women who have planned or received conventional breast MRI imaging at UNC Hospitals will be recruited for the study. Participants will be scanned with the DBT system after the administration of iodinated contrast agent. Images will be acquired prior to the administration of contrast, followed by at approximately 2 minutes and 5 minutes. For the purposes of this study, imaging will focus on a single breast to simplify data acquisition.

Inclusion Criteria:

• Women at least 18 years old
• Planned or received conventional breast MRI at UNC Hospitals within 3 months prior to or after the research scan
• Suspected breast lesion based on prior imaging (BIRADS 4 or greater)
• Able to provide written informed consent

Exclusion Criteria:

• Severe untreatable claustrophobia
• Implanted metallic devices, parts, vascular clips, or other foreign bodies (including breast implants)
• Known hypersensitivity to iodinated contrast agent or to any component of iodinated contrast refractory to standard medications (antihistamines, steroids)
• Impaired kidney function (serum creatinine level > 1.8 mg/dl or a glomerular filtration rate < 60 as approximated using serum creatinine levels within the last 30 days prior to the research scan) unless anuric and on dialysis
• Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours prior to the research scan, or on the basis of patient history, as defined by the UNC IRB SOP 4801)

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

9 to 36 months following publication

The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.