Breast Cancer Clinical Trial
Official title:
A Retrospective, Observational, Case‐Controlled, Multi‐Reader, Multi‐Case, Receiver Operating Characteristic (ROC) Study of Reader Performance When SoftVue Automated Breast Ultrasound (SV) and Digital Screening Mammography (DM) Are Combined, Compared to Screening Mammography Alone, in Asymptomatic Women With Heterogeneous or Extremely Dense Breast Parenchyma.
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.
n/a
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