Study Results
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View full resultsBasic Information
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COMPLETED
NA
3521 participants
INTERVENTIONAL
2009-09-30
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Subjects undergoing breast cancer screening
The study population included both women undergoing routing annual mammography imaging and women undergoing a previously scheduled breast biopsy
Hologic Selenia Dimensions Digital Breast Tomosynthesis System
Subjects are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects undergoing a biopsy procedure will be imaged on the investigational device prior to their procedure.
Interventions
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Hologic Selenia Dimensions Digital Breast Tomosynthesis System
Subjects are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects undergoing a biopsy procedure will be imaged on the investigational device prior to their procedure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Any ethnic origin
* No contraindication of routine bilateral mammography
Exclusion Criteria
* Significant existing breast trauma
* Pregnancy
* Lactating
* Previous surgical biopsy
* Previous breast cancer
* Placement of an internal breast marker
* Breast implants
* Unable to understand and execute written informed consent
* Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single exposure
18 Years
110 Years
FEMALE
No
Sponsors
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Hologic, Inc.
INDUSTRY
Responsible Party
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Locations
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Scottsdale Medical Imaging Ltd. (SMIL)
Scottsdale, Arizona, United States
Hoag Memorial Hospital
Newport Beach, California, United States
UC Davis
Sacramento, California, United States
Invision/Sally Jobe
Greenwood Village, Colorado, United States
Boca Raton Community Hospital
Boca Raton, Florida, United States
Memorial Florida
Hollywood, Florida, United States
Luthern General - Advocate Health Care
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Spectrum Health
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Barnes Jewish
St Louis, Missouri, United States
Elizabeth Wende Breast Clinic
Rochester, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
York - Women's Imaging at Apple Hill
York, Pennsylvania, United States
UTSW Center for Breast Care
Dallas, Texas, United States
Memorial Hermann/ Memorial City
Houston, Texas, United States
Intermountain Medical Imaging
Murray, Utah, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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09-03
Identifier Type: -
Identifier Source: org_study_id
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