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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 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04260620
Study type Observational
Source Delphinus Medical Technologies, Inc.
Contact
Status Completed
Phase
Start date February 8, 2020
Completion date March 3, 2020

See also
  Status Clinical Trial Phase
Completed NCT03972605 - Delphinus SoftVue™ ROC Reader Study