NCT01542814

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

1.3 years

First QC Date

February 27, 2012

Last Update Submit

October 23, 2013

Conditions

Breast Cancer

Keywords

Screening MammogramDiagnostic MammogramBenignMalignantBI-RADS Categories

Outcome Measures

Primary Outcomes (1)

  • Acquire screening cases with and without breast cancer.

    18-months

Study Arms (2)

Fujifilm 3Dimensional Mammography

Group of subjects being given Fujifilm 3D Mammography Imaging

Device: 2D FFDM

2D FFDM

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

Device: 3Dimensional Mammography

Interventions

3Dimensional MammographyDEVICE

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.

Also known as: FUJIFILM 3Dimensional Mammography
2D FFDM
2D FFDMDEVICE

Standard of care screening mammogram.

Fujifilm 3Dimensional Mammography

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Scottsdale Medical Imaging, Limited (SMIL)

Scottsdale, Arizona, 85258, United States

Location

Emory University Healthcare

Atlanta, Georgia, 30322, United States

Location

Elizabeth Wende Breast Care, LLC (EWBC)

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carl J. D'Orsi, MD

    Emory University Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 2, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations

US(3)