Breast Cancer Clinical Trial
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer
Summary
The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.
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.
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
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There is 1 Location for this study
Norwalk Connecticut, 06851, United States
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