Status:
COMPLETED
A Comparison of the 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography for Breast Abnormalities
Lead Sponsor:
Hologic, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
NA
Brief Summary
The purpose of this study is to conduct an initial investigation into whether an alternative method of using 3D imaging might offer accurate diagnostic performance at a reduced patient radiation expos...
Eligibility Criteria
Inclusion
- Subject is female of any race and ethnicity
- Subject is at least 40 years old
- The screening and diagnostic mammograms were performed at the recruiting institution on a Hologic Selenia System
- Subject is categorized as BI-RADS 0 because if mass, density, or calcifications detected on the basis of screening or diagnostic mammography
- Subject will undergo study imaging within 30 days of standard of care imaging
Exclusion
- Patients who are pregnant or think they may be pregnant
- Patients who are breast feeding
- Subjects unable or unwilling to undergo informed consent
- Subjects with breast implants
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00990483
Start Date
October 1 2009
End Date
October 1 2010
Last Update
February 29 2024
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52242