NCT02685566

Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program

A Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Adequacy of the Fujifilm Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) Reader Training Program - A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• 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 assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation of FFDM and DBT images.

Detailed description

For this reader study, radiologists review images obtained via protocol FMSU2013-004A. They review both FFDM alone and FFDM + DBT images, and provide a BI-RADS and POM for each. The radiologists performance metrics for the following modalities will be evaluated: FFDM and FFDM + DBT.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	FFDM Plus DBT	FujiFilm Aspire Cristalle System
DEVICE	FFDM	FujiFilm Aspire Cristalle System

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-08-01
• Completion: 2015-10-01
• First posted: 2016-02-18
• Last updated: 2023-09-21
• Results posted: 2020-06-09

Locations

5 sites across 1 country: United States