A Multi-Reader Multi-Case Pivotal Trial

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