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

October 23, 2013 updated by: Fujifilm Medical Systems USA, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acquire screening cases with and without breast cancer.
Time Frame: 18-months
18-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujifilm Medical Systems USA, Inc.

Investigators

  • Principal Investigator: Carl J. D'Orsi, MD, Emory University Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (Estimate)

March 2, 2012

Study Record Updates

Last Update Posted (Estimate)

October 25, 2013

Last Update Submitted That Met QC Criteria

October 23, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FMSU2011-003A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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