Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography
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About
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:
- Reduce the recall rate And/or
- Improve ROC area due to improved breast cancer detection and/or improved lesion classification.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Female
- Any ethnic origin
- No contraindication for screening mammography
Exclusion criteria
- 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
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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