Simulated Screening Study of Combined Digital X-Ray, Ultrasound and Photoacoustic Breast Imaging
This is a pilot, simulated breast cancer screening study. In a population enriched with
mammographic call-backs, we will study whether:
1) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated
ultrasound(AUS)will result in a lower call-back rate than digital breast
2. Explore the utility of photoacoustic imaging as an adjunct to digital breast
This study will compare two new breast imaging systems to digital mammography and hand-held
ultrasound that are commonly used to find and evaluate breast masses. Images will be done
with digital breast tomosynthesis (DBT) and 3-D automated ultrasound(AUS) which will be done
in the breast imaging clinic of the main hospital followed by the second light and
ultrasound imaging that will be completed in the research lab.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Evaluation of new breast imaging devices
To determine if photoacoustic imaging is an adjunct to standard of care imaging with regards to quality of imaging. and ultrasound modalities and to determine if combining digital breast tomosynthesis and 3 dimensional automated ultrasound will result in a lower call-back ratio than imaging with digital breast tomosynthesis alone.
United States: Institutional Review Board
|University of Michigan Hospital||Ann Arbor, Michigan 48109|