DMT SV RRS1: Delphinus SoftVue™ ROC Reader Study

Sponsor

Delphinus Medical Technologies, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03698942

Collaborator

University of Chicago (Other), Biostatistics Consulting, LLC (Other), Reed Technical Associates, LLC (Other)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Breast Neoplasms	Device: Reading of Automated Breast Ultrasound in conjunction with Screening Mammography

Study Design

Study Type:

Observational

Actual Enrollment :

6 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official 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.

Actual Study Start Date :

Sep 23, 2018

Actual Primary Completion Date :

Sep 23, 2018

Actual Study Completion Date :

Sep 23, 2018

Outcome Measures

Primary Outcome Measures

MRMC Analysis: ROC AUC [8 Weeks]
Area under the ROC curve (AUC)

Secondary Outcome Measures

Sensitivity and Specificity [8 Weeks]
True Positive Rate and True Negative Rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.