Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)

Delphinus Medical Technologies, Inc.32 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 reader study will include up to 32 radiologist readers and a sample of 140 breast screening cases that were selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phase B. The reader study image case set will be enriched with cancer cases.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer Detection Dense Breast Parenchyma Benign Breast Findings Normal Breast Screening Abnormal Breast Screening

Interventions

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 base Inclusion Criteria: * Hold a current United States medical license * Be American Board of Radiology Certified * Be MQSA-qualified * Be experienced in reading DM images on a monitor * Be experienced in reading Breast Ultrasound images on a monitor * 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