Simulated Screening Study for Breast Imaging
Condition: Breast Cysts; Breast Tumors
MeSH terms: Breast Neoplasms; Breast Cyst
Study type: Observational

Summary: 
      This is a pilot, simulated breast cancer screening study. The goal of the study is to explore
      these scanning modalities:

      1) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated
      ultrasound(AUS)

      2. Explore the utility of photoacoustic imaging as an adjunct to digital breast
      tomosynthesis(DBT)/ultrasound(US)alone.
    

Detailed description: 
      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
      tomosynthesis(DBT)alone.

      2. Explore the utility of photoacoustic imaging as an adjunct to digital breast
      tomosynthesis(DBT)/ultrasound(US)alone.

      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.
    

Intervention name(s): X-ray and ultrasound imaging scanning; Photoacoustic imaging scans for breast cancer screening
Intervention type(s): Procedure; Procedure
Intervention description(s): Digital tomosynthesis mammogram uses a low radiation dose, taking x-ray pictures of the breast from many angles to make a 3D(dimensional)image. The participant will be seated and her breast positioned as in a normal mammogram, though with reduced pressure. The x-ray tube will move quickly above the breast to take the images. Then, an ultrasound scan will be done using gel on your breast to assist in acquiring quality imaging.; The participant will be seated in front of the laser device with the breast positioned on the laser device platform. Each subject will be given a laser protective eye mask/goggles to wear and will be instructed how to wear the mask/goggles during the scan. In addition pulse monitor leads may be placed on the participant's chest to allow the computer to record ultrasound blood flow in the breast. The low intensity laser light will be focused on the targeted area of the breast.
Other intervention name(s): Digital tomosynthesis mammogram and automated ultrasound; Optoacoustic Imaging
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population includes women who have had a mammogram at University of Michigan
        within one year who have been referred to the study. Participants may have a breast mass,
        either benign or cancerous.
      
Keywords: automated ultrasound imaging (AUS); digital breast tomosynthesis (DBT); photoacoustic imaging (PAT)