Spots Global Cancer Trial Database for Delphinus SoftVue™ ROC Reader Study
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Trial Identification
Brief Title: Delphinus SoftVue™ ROC Reader Study
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.
Study ID: NCT03698942
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Chicago, Chicago, Illinois, United States
Contact Details
Name: Yulei Jiang, Ph.D
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR
Name: Mary Ellen Giger, Ph.D
Affiliation: Univeristy of Chicago
Role: PRINCIPAL_INVESTIGATOR
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