Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography
Completed · Not applicable
Conditions studied: Breast Cancer
In brief
This was a multi-center, prospective clinical trial in which the subject was her own control. Approximately 950-1400 female subjects were enrolled at five (5) sites in the United States. Subjects were from either a Screening population or a biopsy population and were imaged first on a conventional 2D full filed digital mammography system then on a 3D tomosynthesis system. The resulting images from the this portion of the study were then randomized into a reader study. The purpose of this clinical study was to compare the 3-D tomosynthesis system used in conjunction with a conventional 2-D digital imaging system (2-D plus 3-D images) to the conventional 2-D digital imaging system (2-D images), and to determine whether the 2-D plus 3-D images compared to the 2-D images alone would: 1. Reduce the recall rate And/or 2. Improve ROC area due to improved breast cancer detection and/or improved lesion classification.
Key facts
- Study ID
- NCT00754598
- Run by
- Hologic, Inc.
- People needed
- 1183
- Starts
- 2006-07-01
- Expected to finish
- 2007-07-01
- Last updated by the study team
- 2022-08-12
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female
- Any ethnic origin
- No contraindication for screening mammography
You may not qualify if…
- Significant breast trauma
- Pregnancy
- Lactating
- Breast implants
- Previous breast cancer
- Previous surgical biopsy
- Placement of an internal breast marker
- Unable to understand and or execute written informed consent
Where it is running
- Yale New Haven Hospital — New Haven, Connecticut, United States
- University of Iowa Medical Center — Iowa City, Iowa, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
- Magee Women's Hospital — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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