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

FujiFilm

Status: Completed

Conditions: Breast Cancer

Treatments: Device: FFDM; Device: FFDM Plus DBT

Study type: Interventional

Funder types: Industry

Identifiers

NCT02685566

FMSU2013-004F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female subjects participating in FMSU004A protocol with known clinical status

Exclusion criteria

• Subjects with unknown clinical status not participating in FMSU004A protocol.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

FFDM Plus DBT

Experimental group

Description:

Breast Images with FFDM and DBT

Treatment:

Device: FFDM Plus DBT

Full-Field Digital Mammography

Active Comparator group

Description:

Breast Images with FFDM alone

Treatment:

Device: FFDM