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

Breast Cancer Clinical Trial

Official title:
A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pilot Study

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03491917
Study type Observational
Source Fujifilm Medical Systems USA, Inc.
Contact
Status Completed
Phase
Start date November 3, 2017
Completion date February 15, 2018
View Details
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