Breast Cancer Clinical Trial
Delphinus SoftVueâ„¢ ROC Reader Study
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 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.
Eligibility Criteria
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 SoftVueâ„¢ training program prior to their participation in a reading session for this study.
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There is 1 Location for this study
Detroit Michigan, 48226, United States
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