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.
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.
