Collection of FUJIFILM's 3Dimensional Mammograms (3DM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01542814
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : October 25, 2013
Information provided by (Responsible Party):
Fujifilm Medical Systems USA, Inc.

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.

Condition or disease Intervention/treatment
Breast Cancer Device: 3Dimensional Mammography Device: 2D FFDM

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

Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acquisition of Mammography Images for Clinical Evaluation of FUJIFILM 3Dimensional Mammography
Study Start Date : February 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Group/Cohort Intervention/treatment
Fujifilm 3Dimensional Mammography
Group of subjects being given Fujifilm 3D Mammography Imaging
Device: 2D FFDM
Standard of care screening mammogram.

Group of Subjects receiving FujiFilm or other FDA Approved 2D Mammography Imaging
Device: 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.
Other Name: FUJIFILM 3Dimensional Mammography

Primary Outcome Measures :
  1. Acquire screening cases with and without breast cancer. [ Time Frame: 18-months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All subjects who are appearing for a routine screening examination or have been referred for further diagnostic evaluation after a screening examination (within 45 days) or have a 4-view mammogram (within 45 days) due to clinical concerns will be eligible to participate in the study.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01542814

United States, Arizona
Scottsdale Medical Imaging, Limited (SMIL)
Scottsdale, Arizona, United States, 85258
United States, Georgia
Emory University Healthcare
Atlanta, Georgia, United States, 30322
United States, New York
Elizabeth Wende Breast Care, LLC (EWBC)
Rochester, New York, United States, 14620
Sponsors and Collaborators
Fujifilm Medical Systems USA, Inc.
Principal Investigator: Carl J. D'Orsi, MD Emory University Healthcare

Responsible Party: Fujifilm Medical Systems USA, Inc. Identifier: NCT01542814     History of Changes
Other Study ID Numbers: FMSU2011-003A
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013

Keywords provided by Fujifilm Medical Systems USA, Inc.:
Screening Mammogram
Diagnostic Mammogram
BI-RADS Categories