Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)

Delphinus Medical Technologies

Status: Completed

Conditions: Normal Breast Screening; Benign Breast Findings; Dense Breast Parenchyma; Breast Cancer Detection; Abnormal Breast Screening

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04260620

DMT-2019.002

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 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.

Enrollment: 32 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 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.