Clinical trial NCT01807754: Simulated Screening Study for Breast Imaging
Official title: Simulated Screening Study of Combined Digital X-Ray, Ultrasound and Photoacoustic Breast Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cysts
Breast Tumors
Keywords: automated ultrasound imaging (AUS)
digital breast tomosynthesis (DBT)
photoacoustic imaging (PAT)
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2013-03-08
Enrollment: 41
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Women with possible masses
* All women should have had mammograms at University of Michigan Health System within 1 year before 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.

Primary outcomes:
measure: Evaluation of new breast imaging devices
timeFrame: 3 years
Secondary outcomes:
measure: Determining the ratio of "patient call backs"
timeFrame: 5 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: Univ. of Michigan
name: Paul L Carson, PhD
role: PRINCIPAL_INVESTIGATOR
References: