Delphinus SoftVue™ ROC Reader Study

Completed

• Conditions: Breast Cancer; Breast Neoplasms

• Registration Number: NCT03698942
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-13
• Study Start: 2018-09-23
• Primary Completion: 2018-09-23
• Study Completion: 2018-09-23
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

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)

University of Chicago; 🇺🇸 Chicago, Illinois, United States