A Multi-Reader Multi-Case Pivotal Trial

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

Total Enrollment

298 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-01-31

Brief Summary

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The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.

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Detailed Description

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The safety and effectiveness of FFDM + DBT are both linked to the ability of radiologists interpreting FFDM + DBT images to accurately diagnose breast cancer. Each study endpoint therefore addresses both safety and effectiveness.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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FFDM Plus DBT

FFDM Plus DBT images are being evaluated as compared to FFDM alone

FFDM Plus DBT

Intervention Type DEVICE

FFDM + DBT Images

FujiFilm Aspire Cristalle System

Full Field Digital Mammography

Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT

FFDM Alone

Intervention Type DEVICE

FFDM Alone Images

Interventions

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FFDM Plus DBT

FFDM + DBT Images

FujiFilm Aspire Cristalle System

Intervention Type DEVICE

FFDM Alone

FFDM Alone Images

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Eligible subjects under protocol FMSU2013-004A, defined as female subjects with known true clinical status and with complete FFDM and DBT examinations, in which there is sufficient anatomical coverage, sufficient contrast, and no significant motion or other artifacts, as determined by the image-acquisition sites.

Exclusion Criteria

* Subjects who are in violation of protocol FMSU2013-004A.
* Subjects with unknown clinical status.
* Any subject whose positive mammogram was not read during the truthing process (see section 8) will not be considered for the pivotal MRMC reader study.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes