A Multi-Reader Multi-Case Pivotal Trial

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FujiFilm

Status

Completed

Conditions

Breast Cancer

Treatments

Device: FFDM Alone
Device: FFDM Plus DBT

Study type

Observational

Funder types

Industry

Identifiers

NCT02692209
FMSU2013-004G

Details and patient eligibility

About

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.

Full description

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.

Enrollment

298 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.
  • Meet none of the exclusion criteria under protocol FMSU2013-004A.

Exclusion criteria

  • Subjects who are in violation of protocol FMSU2013-004A.
  • Subjects who meet exclusion criteria under 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.

Trial design

298 participants in 2 patient groups

FFDM Plus DBT
Description:
FFDM Plus DBT images are being evaluated as compared to FFDM alone
Treatment:
Device: FFDM Plus DBT
Full Field Digital Mammography
Description:
Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT
Treatment:
Device: FFDM Alone

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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