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

This study has been completed.
Information provided by (Responsible Party):
Fujifilm Medical Systems USA, Inc. Identifier:
First received: February 27, 2012
Last updated: October 23, 2013
Last verified: October 2013
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 Intervention Phase
Breast Cancer Device: 3Dimensional Mammography Device: 2D FFDM Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acquisition of Mammography Images for Clinical Evaluation of FUJIFILM 3Dimensional Mammography

Resource links provided by NLM:

Further study details as provided by Fujifilm Medical Systems USA, Inc.:

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

Enrollment: 600
Study Start Date: February 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Fujifilm Medical Systems USA, Inc. Identifier: NCT01542814     History of Changes
Other Study ID Numbers: FMSU2011-003A
Study First Received: February 27, 2012
Last Updated: October 23, 2013

Keywords provided by Fujifilm Medical Systems USA, Inc.:
Screening Mammogram
Diagnostic Mammogram
BI-RADS Categories processed this record on September 21, 2017