Collection of FUJIFILM's 3Dimensional Mammograms



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - Any
Updated:5/27/2013
Start Date:February 2012
End Date:May 2013
Contact:Ellen M. D'Orsi, RT(M)
Email:elibert@emory.edu
Phone:404.778.3309

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


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.


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).
We found this trial at
3
sites
Scottsdale, Arizona 85258
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Scottsdale, AZ
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Atlanta, Georgia 30322
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Atlanta, GA
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Rochester, New York 14620
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Rochester, NY
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