Study of Monochromatic X-ray Mammography System

Study of Monochromatic X-ray Mammography System

A research study to find out if an investigational mammography machine is effective in producing high-quality images using a lower radiation dose than traditional mammography.

Prospective, single-arm, non-blinded, comparative/observational study.

Phase 1: Verify operation of monochromatic system and optimize the monochromatic energies and exposure times for a range of breast thicknesses.

Phase 2: Test the performance of the monochromatic system in comparison to traditional 2-D mammography for a range of clinical/imaging scenarios.

Phase 3: Test the performance of the monochromatic system using reduced breast compression.

Inclusion Criteria:

• Female
• 40 yrs of age or older
• Capable of giving informed consent
• Prior history of mammography

Exclusion Criteria:

• Pregnancy
• History of breast cancer surgery, including lumpectomy or mastectomy
• Currently undergoing treatment for breast cancer
• Previous breast augmentations