Delphinus SoftVue™ ROC Reader Study

NCT03972605 | Completed FDA Device

• 1 other identifier: DMT-2019.001
• Study Type: observational
• Target: 32
• 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 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.

Conditions

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

Keywords

Breast Screening; Breast Imaging; SoftVue; Mammography; Ultrasound; Reader Study; ROC AUC; Dense Breasts; Breast Density; Dense Breast Tissue; Breast Neoplasms

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 Adjunctive SoftVue 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 from consented participants 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 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.

Sponsors & Collaborators

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

Study Sites (1)

Cobo Center

Detroit, Michigan, 48226, 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: May 31, 2019
• First Posted: June 3, 2019
• Study Start: June 8, 2019
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)