Delphinus SoftVue™ ROC Reader Study (DMT SV RRS1)

Delphinus Medical Technologies

Status: Completed

Conditions: Breast Cancer; Breast Neoplasms

Treatments: Device: Reading of Automated Breast Ultrasound in conjunction with Screening Mammography

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03698942

DMT-2015.002

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.