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 reader study will include approximately 32 radiologist readers and a sample of approximately 200 breast screening cases to be selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phases B, C, and D. The reader study image case set will be enriched with cancer cases.

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Key information

Conditions

Breast Cancer Detection Abnormal Breast Screening Benign Breast Findings Breast Diseases Breast Neoplasms Dense Breast Parenchyma Neoplasms Neoplasms by Site Normal Breast Screening Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Cobo Center

Detroit, Michigan, 48226, 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 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.

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 Adjunctive SoftVue 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

Boston Biomedical Associates
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 RRS2

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Jun 3, 2019
Registry last updated: Jan 28, 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