Breast Cancer Clinical Trial

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Delphinus SoftVueâ„¢ ROC Reader Study

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Summary

The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVueâ„¢ 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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Eligibility Criteria

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 SoftVueâ„¢ training program prior to their participation in a reading session for this study.

Study is for people with:

Breast Cancer

Estimated Enrollment:

6

Study ID:

NCT03698942

Recruitment Status:

Completed

Sponsor:

Delphinus Medical Technologies, Inc.

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There is 1 Location for this study

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University of Chicago
Chicago Illinois, 60637, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

6

Study ID:

NCT03698942

Recruitment Status:

Completed

Sponsor:


Delphinus Medical Technologies, Inc.

How clear is this clinincal trial information?

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