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Simulated Screening Study of Combined Digital X-Ray, Ultrasound and Photoacoustic Breast Imaging

30 Years
80 Years
Open (Enrolling)
Breast Cysts, Breast Abnormalities, Breast Tumors

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Trial Information

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.

Inclusion Criteria:

- Women with possible masses

- All women should have had mammograms within 1 year previous to this research study.

Exclusion Criteria:

- Women who are physically unable to tolerate the length of the scan.

- Women who are less than 30 years of age or older than 80 years of age

- Women who are pregnant or lactating

- Women whose mass is in an area of the breast which makes it difficult to see in the
research scans

- Womens with a single diagnosis of mammographic calcifications

- Women who have had a breast cancer with lumpectomy

- Women who are prisoners

- Women who are students or staff of investigators

- Women who cannot give consent

- Women with mammograms classified as probably benign because of follow-up of a recent
benign biopsy.

- Women with breast pain who have been categorized as BIRADS(Breast Imaging Reporting
and Data System) category 0(incomplete) on their most recent mammograms.

- Males, because their breast tissue is not easily imaged and numbers of potential
cases are too few.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Evaluation of new breast imaging devices

Outcome Description:

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.

Outcome Time Frame:

3 years

Safety Issue:



United States: Institutional Review Board

Study ID:

HUM 00069294



Start Date:

December 2012

Completion Date:

December 2016

Related Keywords:

  • Breast Cysts
  • Breast Abnormalities
  • Breast Tumors
  • automated ultrasound imaging (AUS)
  • digital breast tomosynthesis (DBT)
  • photoacoustic imaging (PAT)
  • Congenital Abnormalities
  • Breast Neoplasms
  • Breast Cyst



University of Michigan Hospital Ann Arbor, Michigan  48109