Delphinus SoftVue™ ROC Reader Study

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03698942

Acronym

DMT SV RRS1

Enrollment

Registered

2018-10-09

Start date

2018-09-23

Completion date

2018-09-23

Last updated

2020-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Breast Neoplasms

Keywords

Breast Screening, Breast Imaging, SoftVue, Mammography, Ultrasound, Reader Study, ROC AUC, Breast Cancer Detection, Dense Breasts, Breast Density, Dense Breast Tissue, Dense Breast Parenchyma

Brief summary

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.

Interventions

DEVICEReading 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.

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
MRMC Analysis: ROC AUC	8 Weeks	Area under the ROC curve (AUC)

Secondary

Measure	Time frame	Description
Sensitivity and Specificity	8 Weeks	True Positive Rate and True Negative Rate

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026