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

FujiFilm

Status: Completed

Conditions: Breast Cancer

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

Study type: Observational

Funder types: Industry

Identifiers

NCT03501693

FMSU2017-002B

Details and patient eligibility

About

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

Full description

This clinical research is a retrospective, pivotal, multi-reader, multi-case (MRMC) study with an enriched sample of 300 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 18 qualified radiologists will independently perform two reads on all (approximately 300) cases. Each reader will read each case both as a FFDM read, and a DBT plus S-View read on the ASPIRE Bellus II workstation.

As its primary endpoint, this study is designed to evaluate whether the area under the receiver operating characteristic (ROC) curve (AUC) based on probability of malignancy (POM) scores and requiring correct lesion localization is statistically non-inferior for DBT plus S-View versus FFDM.

Enrollment: 300 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

300 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:

FFDM alone images

Treatment:

Device: FFDM Alone