Breast Cancer Clinical Trial

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Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program

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Summary

The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation of FFDM and DBT images.

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Full Description

For this reader study, radiologists review images obtained via protocol FMSU2013-004A. They review both FFDM alone and FFDM + DBT images, and provide a BI-RADS and POM for each. The radiologists performance metrics for the following modalities will be evaluated: FFDM and FFDM + DBT.

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Eligibility Criteria

Inclusion Criteria:

Female subjects participating in FMSU004A protocol with known clinical status

Exclusion Criteria:

Subjects with unknown clinical status not participating in FMSU004A protocol.

Study is for people with:

Breast Cancer

Estimated Enrollment:

100

Study ID:

NCT02685566

Recruitment Status:

Completed

Sponsor:

Fujifilm Medical Systems USA, Inc.

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There are 5 Locations for this study

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Scottsdale Medical Imaging, Limited (SMIL)
Scottsdale Arizona, 85258, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Elizabeth Wende Breast Care, LLC (EWBC)
Rochester New York, 14620, United States
University of North Carolina - at Chapel Hill
Chapel Hill North Carolina, 27599, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
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How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

100

Study ID:

NCT02685566

Recruitment Status:

Completed

Sponsor:


Fujifilm Medical Systems USA, Inc.

How clear is this clinincal trial information?

Clinical Trial Resources

SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
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