Collection of FUJIFILM's 3Dimensional Mammograms

NCT ID: NCT01542814

Last Updated: 2013-10-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-06-30

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.

Detailed Description

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

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Fujifilm 3Dimensional Mammography

Group of subjects being given Fujifilm 3D Mammography Imaging

2D FFDM

Intervention Type: DEVICE

Standard of care screening mammogram.

2D FFDM

Group of Subjects receiving FujiFilm or other FDA Approved 2D Mammography Imaging

3Dimensional Mammography

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

2D FFDM

Standard of care screening mammogram.

Intervention Type: DEVICE

Other Intervention Names

FUJIFILM 3Dimensional Mammography

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.

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fujifilm Medical Systems USA, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl J. D'Orsi, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Healthcare

Locations

Scottsdale Medical Imaging, Limited (SMIL)

Scottsdale, Arizona, United States

Emory University Healthcare

Atlanta, Georgia, United States

Elizabeth Wende Breast Care, LLC (EWBC)

Rochester, New York, United States

Countries

United States

Other Identifiers

FMSU2011-003A

Identifier Type: -

Identifier Source: org_study_id