Delphinus SoftVue™ ROC Reader Study — DMT SV RRS2  

Abnormal Breast Screening 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.

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Abnormal Breast Screening
• Benign Breast Findings
• Breast Cancer Detection
• Dense Breast Parenchyma
• Normal Breast Screening
• Signs and Symptoms

• NCT number: NCT03972605
• Study type: Observational
• Source: Delphinus Medical Technologies, Inc.
• Status: Completed
• Start date: June 8, 2019
• Completion date: July 2, 2019