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

N/ACompletedNCT03491917

Fujifilm Medical Systems USA, Inc.100 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Breast Cancer

Interventions

DBT plus S-ViewDEVICE

DBT plus S-View images

FFDM aloneDEVICE

FFDM alone images

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

International HealthCare, LLC

Norwalk, Connecticut, United States

Outcomes

Primary Outcomes

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

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.

Time frame: 2 visits with 4 week washout period

Data from ClinicalTrials.gov

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