Delphinus SoftVue™ ROC Reader Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-23

Study Completion Date

2018-09-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Breast Neoplasms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Digital Screening Mammography with SoftVue Supplemental Screening Whole Breast Ultrasound

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No