Delphinus SoftVue™ ROC Reader Study

NCT03698942 | Completed FDA Device

• 1 other identifier: DMT-2015.002
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Neoplasms

Keywords

Breast Screening; Breast Imaging; SoftVue; Mammography; Ultrasound; Reader Study; ROC AUC; Breast Cancer Detection; Dense Breasts; Breast Density; Dense Breast Tissue; Dense Breast Parenchyma

Outcome Measures

Primary Outcomes (1)

• MRMC Analysis: ROC AUC

  Area under the ROC curve (AUC)

  8 Weeks

Secondary Outcomes (1)

• Sensitivity and Specificity

  8 Weeks

Interventions

Reading of Automated Breast Ultrasound in conjunction with Screening Mammography DEVICE

Reader performance when SoftVue automated breast ultrasound (SV) and digital screening mammography (DM) are combined, compared to screening mammography alone.

Also known as: Digital Screening Mammography with SoftVue Supplemental Screening Whole Breast Ultrasound

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Readers will evaluate mammography and SoftVue images acquired at study entry in protocol DMT 2015.001 and subsequently categorized into the following case types, in random order: * Cancer cases, confirmed by breast biopsy with at least one lesion determined to be malignant during participation * Non-Cancer cases including, but not limited to benign cases, confirmed by breast biopsy with no lesions determined to be malignant, or normal/negative screening or diagnostic imaging during participation

You may qualify if:

• 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.

Sponsors & Collaborators

• Delphinus Medical Technologies, Inc.: lead
• University of Chicago: collaborator
• Biostatistics Consulting, LLC: collaborator
• Reed Technical Associates, LLC: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yulei Jiang, Ph.D

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Mary Ellen Giger, Ph.D

  Univeristy of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: October 9, 2018
• Study Start: September 23, 2018
• Primary Completion: September 23, 2018
• Study Completion: September 23, 2018
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)