Breast Cancer
Conditions
Keywords
Breast Cancer, digital mammography, tomosynthesis
Brief summary
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.
Interventions
DEVICETomosynthesis digital mammography imaging system
a full-field digital mammography system where multiple images are acquired at various angles near the normal to the detector. Breast compression is performed in a standard geometry. The acquired images are reconstructed using mathematical algorithms, not unlike CT reconstructions, to generate a set of thin slices parallel to the breast platform. The reconstructed slices can be viewed individually or in a movie format.
Sponsors
Hologic, Inc.
Study design
Allocation
NON_RANDOMIZED
Primary purpose
DIAGNOSTIC
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To detect a 20% reduction in the recall rate when comparing the recall rate using the BIRADS 0 scores of the 2-D plus 3-D images to the 2-D images. | 10-12 months |
Secondary
| Measure | Time frame |
|---|---|
| To detect a 0.05 increase in the area under the ROC curve when comparing 2-D plus 3-D images to the 2-D images. | 10-12 months |
Countries
United States
Outcome results
None listed