Lack of accrual

The purpose of this study is to test whether contrast-enhanced spectral mammography (CESM) may be able to reduce the number of unnecessary biopsies in women whose screening mammograms had abnormal findings.

Inclusion Criteria:

• Women called back from a screening mammography by either FFDM or tomosynthesis with soft tissue abnormalities including masses, asymmetries, focal asymmetries or architectural distortion with or without calcifications. Patients will be questioned regarding the possibility of pregnancy and will need a negative pregnancy test prior the study intervention.

Exclusion Criteria:

• Age <30 years old
• Screening mammography with only calcifications abnormalities
• Male patients
• Pregnant or lactating patients
• Patients with any allergy to iodinated contrast
• Patients with eGFR < 45
• Patients that may be treated with radioactive iodine

Women called back from a screening mammography by either FFDM or tomosynthesis with soft tissue abnormalities including masses, asymmetries, focal asymmetries or architectural distortion with or without calcifications.

Women called back from an abnormal screening mammogram/tomosynthesis exam will be offered CESM as part of their diagnostic work up.

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.