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

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 Pivotal Study

Status Completed

Clinical Trial Summary

The purpose of the pivotal reader study is to assess the comparative accuracy of Fujifilm DBT plus S-View versus FFDM in the detection of breast cancer.

Clinical Trial Description

This clinical research is a retrospective, pivotal, multi-reader, multi-case (MRMC) study with an enriched sample of 300 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 18 qualified radiologists will independently perform two reads on all (approximately 300) cases. Each reader will read each case both as a FFDM read, and a DBT plus S-View read on the ASPIRE Bellus II workstation.

As its primary endpoint, this study is designed to evaluate whether the area under the receiver operating characteristic (ROC) curve (AUC) based on probability of malignancy (POM) scores and requiring correct lesion localization is statistically non-inferior for DBT plus S-View versus FFDM. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT03501693
• Study type: Observational
• Source: Fujifilm Medical Systems USA, Inc.
• Status: Completed
• Start date: April 6, 2018
• Completion date: August 31, 2018