Delphinus SoftVue™ ROC Reader Study

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reading of Automated Breast Ultrasound in conjunction with Screening Mammography

Device

Reader performance when SoftVue automated breast ultrasound (SV) and digital screening mammography (DM) are combined, compared to screening mammography alone.

Other names: Digital Screening Mammography with SoftVue Supplemental Screening Whole Breast Ultrasound

Primary outcomes

MRMC Analysis: ROC AUC

Time frame: 8 Weeks

Area under the ROC curve (AUC)

Secondary outcomes

Sensitivity and Specificity

Time frame: 8 Weeks

True Positive Rate and True Negative Rate

Sponsors and collaborators

Lead sponsor

Delphinus Medical Technologies, Inc.

Industry

Collaborators

Biostatistics Consulting, LLC
Reed Technical Associates, LLC
University of Chicago

Registry information

Official study title

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.

Acronym: DMT SV RRS1

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Oct 9, 2018
Registry last updated: Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed