Delphinus SoftVue™ ROC Reader Study

Completed

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

• Registration Number: NCT03972605
• Lead Sponsor: Delphinus Medical Technologies, Inc.

Brief 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 approximately 32 radiologist readers and a sample of approximately 200 breast screening cases to be selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phases B, C, and D. The reader study image case set will be enriched with cancer cases.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Study Start: 2019-06-08
• Primary Completion: 2019-07-02
• Study Completion: 2019-07-02
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MRMC Analysis: ROC AUC	8 Weeks	Area under the ROC curve (AUC)

Secondary Outcome Measures

Name	Time	Method
Sensitivity and Specificity	8 Weeks	True Positive Rate and True Negative Rate

Trial Locations

Locations (1)

Cobo Center; 🇺🇸 Detroit, Michigan, United States