Acquisition and Clinical Image Evaluation of Fujifilm's High Resolution (HR) Digital Breast Tomosynthesis (DBT) Images.

Acquisition and Clinical Image Evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) Images

Acquisition and clinical image evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) images.

This study is designed to acquire Fujifilm DBT HR mode images and following image acquisition, includes a Clinical Image Evaluation study to assess whether Fujifilm HR DBT images are of sufficiently acceptable quality for use in clinical mammography.

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).