Collection of FUJIFILM's 3Dimensional Mammograms

Study Overview
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Brief Summary
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This image-acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. The acquired data will be used to support FUJIFILM protocol FMSU2011-003B (Clinical Evaluation of FUJIFILM 3Dimensional Digital Mammography) and future regulatory submissions.

Detailed Description
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This is an image acquisition reader study to observe differences between 3D FujiFilm Mammography and 2D approved Mammography

Official Title
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Acquisition of Mammography Images for Clinical Evaluation of FUJIFILM 3Dimensional Mammography

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: 3Dimensional Mammography
* Device: 2D FFDM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female. Any ethnic or racial origin. Must come through the study via the screening or diagnostic pathway described above. Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol. Meet none of the exclusion criteria. Exclusion Criteria: • Presence of a breast implant. Women with only a single breast; for example, post mastectomy patients. Is pregnant or believes she may be pregnant. A woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding. A woman who has significant existing breast trauma. Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate mammography examinations. A woman who has had a mammogram performed for the purpose of therapy portal planning. Inadequate technical quality mammography images, such as insufficient anatomical coverage or significant motion artifacts. Cannot, for any known reason, undergo follow-up mammography examinations (where clinically indicated) at the participating institution. Is an inmate (see US Code of Federal Regulations 45CFR46.306).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fujifilm 3Dimensional Mammography<br>Group of subjects being given Fujifilm 3D Mammography Imaging | Device: 2D FFDM<br>* Standard of care screening mammogram.<br>|
| 2D FFDM<br>Group of Subjects receiving FujiFilm or other FDA Approved 2D Mammography Imaging | Device: 3Dimensional Mammography<br>* The FUJIFILM 3DM examination is a 4-view mammogram which includes CC and MLO views of each breast. For each view, a routine (0-degree) mammogram will be acquired followed immediately in the same compression by a second mammogram offset at 4 degrees.<br>* Other names: FUJIFILM 3Dimensional Mammography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acquire screening cases with and without breast cancer. |  | 18-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening Mammogram, Diagnostic Mammogram, Benign, Malignant, BI-RADS Categories