Spots Global Cancer Trial Database for Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer

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Trial Identification

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

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

Study ID: NCT03491917

Conditions

Breast Cancer

Interventions

DBT plus S-View

FFDM alone

Study Description

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

Detailed 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.