Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Controlled Clinical Trial to Evaluate the Hologic 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Tomosynthesis digital mammography imaging system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Tomosynthesis 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, digital mammography, tomosynthesis