Breast Cancer
Conditions
Keywords
Screening Mammogram, Diagnostic Mammogram, Benign, Malignant, BI-RADS Categories
Brief summary
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
This is an image acquisition reader study to observe differences between 3D FujiFilm Mammography and 2D approved Mammography
Interventions
DEVICE3Dimensional 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.
DEVICE2D FFDM
Standard of care screening mammogram.
Sponsors
Fujifilm Medical Systems USA, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes
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
.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acquire screening cases with and without breast cancer. | 18-months |
Countries
United States
Outcome results
None listed