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

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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)

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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