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Collection of FUJIFILM's 3Dimensional Mammograms

NCT01542814 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2013-10-25

No results posted yet for this study

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.

Conditions

Interventions

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.

DEVICE

2D FFDM

Standard of care screening mammogram.

Sponsors & Collaborators

  • Fujifilm Medical Systems USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Carl J. D'Orsi, MD · Emory University Healthcare

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01542814 on ClinicalTrials.gov