CompletedN/ADMT

Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)

NCT ID

NCT04260620

Target Enrollment

32 participants

Start Date

2020-02-08

Est. Completion

2020-03-03

About This Study

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.

Conditions Studied

Breast Cancer DetectionDense Breast ParenchymaBenign Breast FindingsNormal Breast ScreeningAbnormal Breast Screening

Interventions

•Reading of Automated Breast Ultrasound in conjunction with Screening Mammography

Eligibility

Healthy Volunteers:No

View full eligibility criteria

Radiologists of any age, sex, race, ethnicity, or institutional affiliation may participate as study readers. All readers must meet the following base Inclusion Criteria:

* Hold a current United States medical license
* Be American Board of Radiology Certified
* Be MQSA-qualified
* Be experienced in reading DM images on a monitor
* Be experienced in reading Breast Ultrasound images on a monitor
* Have completed a Financial Disclosure showing no Conflicts of Interest
* Have provided a current curriculum vitae (CV)
* Have provided a signed Readers' Agreement
* Have provided written Informed Consent

All qualified and confirmed readers will complete a multi-module SoftVue™ training program prior to their participation in a reading session for this study.

Study Locations (1)

Delphinus Medical Technologies, Inc.