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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

International HealthCare, LLC

Norwalk, Connecticut, 06851, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBT plus S-View

Device

DBT plus S-View images

FFDM alone

Device

FFDM alone images

Primary outcomes

Compare Per Subject Average Area Under the ROC (Receiver Operating Characteristic) Curve (AUC)

Time frame: 2 visits with 4 week washout period

Compare per subject average area under the ROC curve (AUC) for DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) versus FFDM (Full Field Digital Mammography), based on per-subject POM (probability of malignancy) scores and requiring correct lesion localization. The primary endpoint was non-inferior per-subject average AUC. Statistician estimated AUCs for each reader in each review condition (FFDM, DBT plus S-View) based on per-subject POM scores requiring correct lesion localization. Statistician also calculated for each reader the non-parametric (trapezoidal) AUC for the FFDM read, the DBT plus S-View read, and the difference between them. These AUC's, differences between them, and the associated variance-covariance matrix were obtained using the method of DeLong, et al.

Sponsors and collaborators

Lead sponsor

Fujifilm Medical Systems USA, Inc.

Industry

Registry information

Official study title

A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pilot Study

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2018
First posted: Apr 9, 2018
Registry last updated: Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed