Breast Cancer Clinical Trial

Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone

Summary

The purpose of this pilot is to provide credible performance estimate information in order to conduct subsequent reader studies.

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Full Description

This pilot reader study was to determine the following:

the radiologist's performance metrics for the two reading modalities, i.e., "FFDM read on the Aspire Bellus workstation" and "FFDM read in conjunction with DBT read on the Aspire Bellus workstation",;
the magnitude and direction of differences between performance metrics for the two modalities; and
variance components and correlations that would influence samples sizes and case mix for the subsequent pivotal reader study comparing performance metrics between the two modalities.

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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:

NCT02511730

Recruitment Status:

Completed

Sponsor:

Fujifilm Medical Systems USA, Inc.

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There are 4 Locations for this study

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Scottsdale Medical Imaging, Limited (SMIL)
Scottsdale Arizona, 85258, 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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

100

Study ID:

NCT02511730

Recruitment Status:

Completed

Sponsor:


Fujifilm Medical Systems USA, Inc.

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