Spots Global Cancer Trial Database for Delphinus SoftVue™ ROC Reader Study

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

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: NCT03972605

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 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.

Detailed Description: