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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: DBT plus S-View
* Device: FFDM alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DBT plus S-View<br>Breast images utilizing DBT plus S-View | Device: DBT plus S-View<br>* DBT plus S-View images<br>|
| FFDM alone<br>Breast images using FFDM alone only | Device: FFDM alone<br>* FFDM alone images<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 visits with 4 week washout period |