Spots Global Cancer Trial Database for Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)

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Trial Identification

Brief Title: Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)

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: NCT04260620

Conditions

Breast Cancer Detection

Dense Breast Parenchyma

Benign Breast Findings

Normal Breast Screening

Abnormal Breast Screening

Interventions

Reading of Automated Breast Ultrasound in conjunction with Screening Mammography

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 reader study will include up to 32 radiologist readers and a sample of 140 breast screening cases that were selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phase B. The reader study image case set will be enriched with cancer cases.

Detailed Description: