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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fujifilm Medical Systems USA, Inc.
ClinicalTrials.gov Identifier:
NCT01542814
First received: February 27, 2012
Last updated: October 23, 2013
Last verified: October 2013

February 27, 2012
October 23, 2013
February 2012
June 2013   (final data collection date for primary outcome measure)
Acquire screening cases with and without breast cancer. [ Time Frame: 18-months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01542814 on ClinicalTrials.gov Archive Site
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Collection of FUJIFILM's 3Dimensional Mammograms
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.

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

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

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.

Breast Cancer
  • 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
  • Device: 2D FFDM
    Standard of care screening mammogram.
  • Fujifilm 3Dimensional Mammography
    Group of subjects being given Fujifilm 3D Mammography Imaging
    Intervention: Device: 2D FFDM
  • 2D FFDM
    Group of Subjects receiving FujiFilm or other FDA Approved 2D Mammography Imaging
    Intervention: Device: 3Dimensional Mammography
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
June 2013
June 2013   (final data collection date for primary outcome measure)

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).
Female
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01542814
FMSU2011-003A
No
Fujifilm Medical Systems USA, Inc.
Fujifilm Medical Systems USA, Inc.
Not Provided
Principal Investigator: Carl J. D'Orsi, MD Emory University Healthcare
Fujifilm Medical Systems USA, Inc.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP