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Delphinus SoftVue™ ROC Reader Study

NCT03972605 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2020-01-28

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 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.

Conditions

  • Breast Cancer Detection
  • Dense Breast Parenchyma
  • Benign Breast Findings
  • Normal Breast Screening
  • Abnormal Breast Screening

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

  • Boston Biomedical Associates

    collaborator OTHER

  • 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
2019-06-08
Primary Completion
2019-07-02
Completion
2019-07-02
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03972605 on ClinicalTrials.gov