Simulated Screening Study for Breast Imaging
Conditions
Breast Cysts - Breast Tumors
Conditions: official terms
Breast Cyst - Breast Neoplasms
Conditions: Keywords
automated ultrasound imaging (AUS), digital breast tomosynthesis (DBT), photoacoustic imaging (PAT)
Study Type
Interventional
Study Phase
Phase 0
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Intervention
Name: Imaging modalities for breast cancer screening Type: Procedure
Name: Imaging modalities for breast cancer screening Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 30 Years
Gender: Female
Criteria: 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.
Location
University of Michigan Hospital
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Paul L Carson, Ph.D - 734-763-5884 - pcarson@umich.edu
Start Date
December 2012
Completion Date
December 2017
Sponsors
University of Michigan
Source
University of Michigan
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page