CompletedNot Applicable

Delphinus SoftVue™ ROC Reader Study

United States32 participantsStarted 2019-06-08

Plain-language 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.

Who can participate

SexALL

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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.

What they're measuring

MRMC Analysis: ROC AUC

Timeframe: 8 Weeks

Trial details

NCT IDNCT03972605

SponsorDelphinus Medical Technologies, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-07-02

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