MedTrace Logo

Delphinus SoftVue™ ROC Reader Study

NCT03698942 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2020-02-07

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Reading 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.

Sponsors & Collaborators

  • University of Chicago

    collaborator OTHER

  • Biostatistics Consulting, LLC

    collaborator UNKNOWN

  • Reed Technical Associates, LLC

    collaborator UNKNOWN

  • Delphinus Medical Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Yulei Jiang, Ph.D · University of Chicago

  • Mary Ellen Giger, Ph.D · Univeristy of Chicago

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-23
Primary Completion
2018-09-23
Completion
2018-09-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03698942 on ClinicalTrials.gov