Delphinus SoftVue™ ROC Reader Study

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 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.

Key facts

Study ID
NCT03972605
Run by
Delphinus Medical Technologies, Inc.
People needed
32
Starts
2019-06-08
Expected to finish
2019-07-02
Last updated by the study team
2020-01-28

Who can join

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

Where it is running

Full record on ClinicalTrials.gov

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