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

NCT ID: NCT02685566

Last Updated: 2023-09-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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FFDM Plus DBT

Breast Images with FFDM and DBT

Group Type EXPERIMENTAL

FFDM Plus DBT

Intervention Type DEVICE

FujiFilm Aspire Cristalle System

Full-Field Digital Mammography

Breast Images with FFDM alone

Group Type ACTIVE_COMPARATOR

FFDM

Intervention Type DEVICE

FujiFilm Aspire Cristalle System

Interventions

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FFDM Plus DBT

FujiFilm Aspire Cristalle System

Intervention Type DEVICE

FFDM

FujiFilm Aspire Cristalle System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female subjects participating in FMSU004A protocol with known clinical status

Exclusion Criteria

* Subjects with unknown clinical status not participating in FMSU004A protocol.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fujifilm Medical Systems USA, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert M Uzenoff

Role: STUDY_DIRECTOR

Fujifilm Medical Systems USA, Inc.

Locations

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Scottsdale Medical Imaging, Limited (SMIL)

Scottsdale, Arizona, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Elizabeth Wende Breast Care, LLC (EWBC)

Rochester, New York, United States

Site Status

University of North Carolina - at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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FMSU2013-004F

Identifier Type: -

Identifier Source: org_study_id

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