Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer

FujiFilm

Status: Completed

Conditions: Breast Cancer

Treatments: Device: FFDM alone; Device: DBT plus S-View

Study type: Observational

Funder types: Industry

Identifiers

NCT03491917

FMSU2017-002A

Details and patient eligibility

About

The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.

Full description

This clinical research is a retrospective, pilot, multi-reader, multi-case (MRMC) study with an enriched sample of 100 breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations). Approximately 6 qualified radiologists will independently perform two reads on all (approximately 100) cases. Each reader will read each case both as a FFDM (Full Field Digital Mammography) read, and a DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) read on the ASPIRE Bellus II workstation.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female subjects participating in FMSU2013-004A protocol with known clinical status

Exclusion criteria

• Female subjects that did not have known clinical status in FMSU2013-004A

Trial design

100 participants in 2 patient groups

DBT plus S-View

Description:

Breast images utilizing DBT plus S-View

Treatment:

Device: DBT plus S-View

FFDM alone

Description:

Breast images using FFDM alone only

Treatment:

Device: FFDM alone