Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)

Completed

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

• Registration Number: NCT04260620
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Study Start: 2020-02-08
• Primary Completion: 2020-03-03
• Study Completion: 2020-03-03
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

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)

Delphinus Medical Technologies, Inc.; 🇺🇸 Novi, Michigan, United States