Clinical Research Directory

Inclusion Criteria: * Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol; * Have the ability to understand and provide written authorization for the use and disclosure of protected health information (PHI) per the Health Insurance Portability and Accountability Act (HIPAA) privacy ruling; * Be female; * Be at least 40 years of age; * Be asymptomatic; and * Have received a final BI-RADS Assessment Category of 1 or 2 (negative or benign findings) on her routine screening mammogram. Exclusion Criteria: * Has a breast implant; * Is pregnant or believes she may be pregnant; * Has delivered and expressed the intention to breast-feed or is currently breast-feeding; * Has significant existing breast trauma with the last one (1) year; * Has any breast symptoms (e.g., breast lump, pain, nipple discharge); * Has been diagnosed or treated for breast cancer within the last year; or * Is an inmate (see US Code of Federal Regulations 45 CFR 46.306).