Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)

Completed

Conditions studied: Breast Cancer Detection, Dense Breast Parenchyma, Benign Breast Findings, Normal Breast Screening, Abnormal Breast Screening

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 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.

Key facts

Study ID
NCT04260620
Run by
Delphinus Medical Technologies, Inc.
People needed
32
Starts
2020-02-08
Expected to finish
2020-03-03
Last updated by the study team
2021-02-03

Who can join

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

Where it is running

Full record on ClinicalTrials.gov

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