Delphinus SoftVue™ ROC Reader Study (DMT SV RRS1)

February 5, 2020 updated by: Delphinus Medical Technologies, Inc.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Readers will evaluate mammography and SoftVue images acquired at study entry in protocol DMT 2015.001 and subsequently categorized into the following case types, in random order:

  • Cancer cases, confirmed by breast biopsy with at least one lesion determined to be malignant during participation
  • Non-Cancer cases including, but not limited to benign cases, confirmed by breast biopsy with no lesions determined to be malignant, or normal/negative screening or diagnostic imaging during participation

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity
Time Frame: 8 Weeks
True Positive Rate and True Negative Rate
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Delphinus Medical Technologies, Inc.

Collaborators

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

Investigators

  • Principal Investigator: Yulei Jiang, Ph.D, University of Chicago
  • Principal Investigator: Mary Ellen Giger, Ph.D, Univeristy of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2018

Primary Completion (Actual)

September 23, 2018

Study Completion (Actual)

September 23, 2018

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMT-2015.002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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