Delphinus SoftVue™ ROC Reader Study
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/10/2018 |
| Start Date: | September 23, 2018 |
| End Date: | September 23, 2018 |
A Retrospective, Observational, Case‐Controlled, Multi‐Reader, Multi‐Case, Receiver Operating Characteristic (ROC) Study of Reader Performance When SoftVue Automated Breast Ultrasound (SV) and Digital Screening Mammography (DM) Are Combined, Compared to Screening Mammography Alone, in Asymptomatic Women With Heterogeneous or Extremely Dense Breast Parenchyma.
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.
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.
Radiologists of any age, sex, race, ethnicity, or institutional affiliation may participate
as study readers. All readers must meet the following Inclusion Criteria:
- Hold a current United States medical license
- Be American Board of Radiology Certified
- Be MQSA‐qualified
- Be experienced in reading FFDM images on a monitor (softcopy)
- Be experienced in reading Breast Ultrasound images on a monitor (softcopy)
- 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.
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University of Chicago One of the world's premier academic and research institutions, the University of...
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