Status:
COMPLETED
Simulated Screening Study for Breast Imaging
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Breast Cysts
Breast Tumors
Eligibility:
FEMALE
30-80 years
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-automa...
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 dim...
Eligibility Criteria
Inclusion
- Women with possible masses
- All women should have had mammograms at University of Michigan Health System within 1 year before this research study.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 23 2020
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01807754
Start Date
December 1 2012
End Date
April 23 2020
Last Update
May 21 2020
Active Locations (1)
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1
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109