Multicenter Hologic Tomosynthesis Study

Study Overview
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Brief Summary
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The purpose of this image acquisition study is to compare, in a Reader Study, the 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 will improve receiver operating characteristic (ROC) area under the curve.

Official Title
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A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Hologic Selenia Dimensions Digital Breast Tomosynthesis System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Any ethnic origin No contraindication of routine bilateral mammography Exclusion Criteria: Any contraindications to mammographic screening, including but not limited to: Significant existing breast trauma Pregnancy Lactating Previous surgical biopsy Previous breast cancer Placement of an internal breast marker Breast implants Unable to understand and execute written informed consent Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single exposure

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Biopsy<br>subjects presenting for a breast biopsy procedure, subject will be imaged before her biopsy procedure with the investigational 2D plus 3D mammography system | Device: Hologic Selenia Dimensions Digital Breast Tomosynthesis System<br>* Subjects are enrolled from either a screening population or a biopsy population. Both groups are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects recruited in the biopsy population will be imaged on the investigational device prior to their biopsy procedure.<br>* Other names: 2D plus 3D breast imaging;|
| Other: screening<br>subjects presenting for routine asymptomatic mammograms and will then have an investigational 2D plus 3D mammogram | Device: Hologic Selenia Dimensions Digital Breast Tomosynthesis System<br>* Subjects are enrolled from either a screening population or a biopsy population. Both groups are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects recruited in the biopsy population will be imaged on the investigational device prior to their biopsy procedure.<br>* Other names: 2D plus 3D breast imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To detect a statistically significant increase in the area under the ROC curve when comparing 2-D plus 3-D images to the 2-D images. The ROC curves will be generated from the probability of malignancy scale, a score of 0% to 100%. |  | Fall 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, breast cancer screening