Study of Monochromatic X-ray Mammography System
Imagine Scientific, Inc.
Summary
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.
Description
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.
Eligibility
- Age range
- 40+ years
- Sex
- Female
- Healthy volunteers
- No
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
Interventions
- Device2-D Monochromatic X-ray Mammography System
Monochromatic x-ray mammography system produces superior images as compared to conventional 2-D and 3-D mammography while using a lower radiation dose.
Location
- Duke Cancer CenterDurham, North Carolina