Breast Cancer Clinical Trial

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Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer

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Summary

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

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Full Description

This clinical research is a retrospective, pilot, multi-reader, multi-case (MRMC) study with an enriched sample of 100 breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations). Approximately 6 qualified radiologists will independently perform two reads on all (approximately 100) cases. Each reader will read each case both as a FFDM (Full Field Digital Mammography) read, and a DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) read on the ASPIRE Bellus II workstation.

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Eligibility Criteria

Inclusion Criteria:

Female subjects participating in FMSU2013-004A protocol with known clinical status

Exclusion Criteria:

Female subjects that did not have known clinical status in FMSU2013-004A

Study is for people with:

Breast Cancer

Estimated Enrollment:

100

Study ID:

NCT03491917

Recruitment Status:

Completed

Sponsor:

Fujifilm Medical Systems USA, Inc.

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There is 1 Location for this study

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International HealthCare, LLC
Norwalk Connecticut, 06851, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

100

Study ID:

NCT03491917

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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