Delphinus SoftVue™ ROC Reader Study

Delphinus Medical Technologies, Inc.6 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer Breast Neoplasms

Interventions

Reading of Automated Breast Ultrasound in conjunction with Screening MammographyDEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

MRMC Analysis: ROC AUC

Area under the ROC curve (AUC)

Time frame: 8 Weeks

Secondary Outcomes

Sensitivity and Specificity

True Positive Rate and True Negative Rate