NCT03491917

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Fujifilm Medical Systems USA, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	DBT plus S-View	DBT plus S-View images
DEVICE	FFDM alone	FFDM alone images

Timeline

• Start date: 2017-11-03
• Primary completion: 2017-12-31
• Completion: 2018-02-15
• First posted: 2018-04-09
• Last updated: 2020-06-18
• Results posted: 2020-06-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study