Study of Monochromatic X-ray Mammography System

Condition(s) studied

Investigational drug(s) / intervention(s)

2-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.

Study 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.

Eligibility

Primary outcome measure(s)

• Noninferiority of a 2-D monochromatic X-ray mammography system compared to conventional mammography — Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)
  Demonstrate that a 2-D monochromatic X-ray mammography system can produce mammographic images using lower radiation dose (at least 20% less than conventional mammography), yet, not inferior to conventional mammography. \[Likert scale 1-3. Higher score is a better outcome\]

Trial sites (1)

Other trials for the same condition