Breast Cancer Clinical Trial

Collection of FUJIFILM’s 3Dimensional Mammograms

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.

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Full Description

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

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Eligibility Criteria

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).

Study is for people with:

Breast Cancer

Estimated Enrollment:

600

Study ID:

NCT01542814

Recruitment Status:

Completed

Sponsor:

Fujifilm Medical Systems USA, Inc.

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There are 3 Locations for this study

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Scottsdale Medical Imaging, Limited (SMIL)
Scottsdale Arizona, 85258, United States
Emory University Healthcare
Atlanta Georgia, 30322, United States
Elizabeth Wende Breast Care, LLC (EWBC)
Rochester New York, 14620, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

600

Study ID:

NCT01542814

Recruitment Status:

Completed

Sponsor:


Fujifilm Medical Systems USA, Inc.

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