Delphinus SoftVue™ ROC Reader Study

Completed

Conditions studied: Breast Cancer, Breast Neoplasms

In brief

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.

Key facts

Study ID
NCT03698942
Run by
Delphinus Medical Technologies, Inc.
People needed
6
Starts
2018-09-23
Expected to finish
2018-09-23
Last updated by the study team
2020-02-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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