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A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography
The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Synthetic 2D images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in CT imaging and to determine whether the 3-D images with the synthesized 2D overview are non-inferior to the 2-D images alone as determined by receiver operating characteristic (ROC) area under the curve.
Age
18 - 110 years
Sex
FEMALE
Healthy Volunteers
No
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
Start Date
September 1, 2009
Primary Completion Date
September 1, 2011
Completion Date
April 1, 2012
Last Updated
February 26, 2025
3,521
ACTUAL participants
Hologic Selenia Dimensions Digital Breast Tomosynthesis System
DEVICE
Lead Sponsor
Hologic, Inc.
NCT04704661
NCT05372640
Data Source & Attribution
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