Delphinus SoftVue™ ROC Reader Study

Study Overview
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Brief Summary
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The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. This includes obtaining information that can be used to properly plan, design, and power future ROC reader studies. This reader study will include a minimum of 6 radiologist readers and an enriched sample of at least 100 breast screening or diagnostic cases to be selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839). The reader study image case set will be enriched with cancer cases.

Official Title
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A Retrospective, Observational, Case-Controlled, Multi-Reader, Multi-Case, Receiver Operating Characteristic (ROC) Study of Reader Performance When SoftVue Automated Breast Ultrasound (SV) and Digital Screening Mammography (DM) Are Combined, Compared to Screening Mammography Alone, in Asymptomatic Women With Heterogeneous or Extremely Dense Breast Parenchyma.

Conditions
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Breast Cancer, Breast Neoplasms

Intervention / Treatment
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* Device: Reading of Automated Breast Ultrasound in conjunction with Screening Mammography


Participation Criteria
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Eligibility Criteria
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Radiologists of any age, sex, race, ethnicity, or institutional affiliation may participate as study readers. All readers must meet the following Inclusion Criteria: Hold a current United States medical license Be American Board of Radiology Certified Be MQSA-qualified Be experienced in reading FFDM images on a monitor (softcopy) Be experienced in reading Breast Ultrasound images on a monitor (softcopy) Have completed a Financial Disclosure showing no Conflicts of Interest Have provided a current curriculum vitae (CV) Have provided a signed Readers' Agreement Have provided written Informed Consent All qualified and confirmed readers will complete a multi-module SoftVue™ training program prior to their participation in a reading session for this study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Reading of Automated Breast Ultrasound in conjunction with Screening Mammography|Reader performance when SoftVue automated breast ultrasound (SV) and digital screening mammography (DM) are combined, compared to screening mammography alone.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRMC Analysis: ROC AUC | Area under the ROC curve (AUC) | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity | True Positive Rate and True Negative Rate | 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Screening, Breast Imaging, SoftVue, Mammography, Ultrasound, Reader Study, ROC AUC, Breast Cancer Detection, Dense Breasts, Breast Density, Dense Breast Tissue, Dense Breast Parenchyma