Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
600 participants
OBSERVATIONAL
2012-02-29
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Fujifilm 3Dimensional Mammography
Group of subjects being given Fujifilm 3D Mammography Imaging
2D FFDM
Standard of care screening mammogram.
2D FFDM
Group of Subjects receiving FujiFilm or other FDA Approved 2D Mammography Imaging
3Dimensional Mammography
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.
Interventions
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3Dimensional Mammography
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.
2D FFDM
Standard of care screening mammogram.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
40 Years
FEMALE
Yes
Sponsors
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Fujifilm Medical Systems USA, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Carl J. D'Orsi, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University Healthcare
Locations
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Scottsdale Medical Imaging, Limited (SMIL)
Scottsdale, Arizona, United States
Emory University Healthcare
Atlanta, Georgia, United States
Elizabeth Wende Breast Care, LLC (EWBC)
Rochester, New York, United States
Countries
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Other Identifiers
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FMSU2011-003A
Identifier Type: -
Identifier Source: org_study_id