Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)

Sponsor
Delphinus Medical Technologies, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04260620
Collaborator
University of Chicago (Other), Boston Biomedical Associates (Other)
32
1
24
40.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Reading of Automated Breast Ultrasound in conjunction with Screening Mammography

Study Design

Study Type:
Observational
Actual Enrollment :
32 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
A Retrospective, Observational, Case-controlled, Multi-reader, Multi-case, Receiver Operating Characteristic (ROC) Study of Reader Performance When SoftVue Automated Breast Ultrasound (SV) and Digital Screening Mammography (DM) Are Combined, Compared to Screening Mammography Alone, in Asymptomatic Women With Heterogeneous or Extremely Dense Breast Parenchyma
Actual Study Start Date :
Feb 8, 2020
Actual Primary Completion Date :
Mar 3, 2020
Actual Study Completion Date :
Mar 3, 2020

Outcome Measures

Primary Outcome Measures

  1. MRMC Analysis: ROC AUC [8 Weeks]

    Area under the ROC curve (AUC)

Secondary Outcome Measures

  1. Sensitivity and Specificity [8 Weeks]

    True Positive Rate and True Negative Rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Radiologists of any age, sex, race, ethnicity, or institutional affiliation may participate as study readers. All readers must meet the following base 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Delphinus Medical Technologies, Inc. Novi Michigan United States 48374

Sponsors and Collaborators

  • Delphinus Medical Technologies, Inc.
  • University of Chicago
  • Boston Biomedical Associates

Investigators

  • Principal Investigator: Yulei Jiang, Ph.D, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Delphinus Medical Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT04260620
Other Study ID Numbers:
  • DMT-2019.002
First Posted:
Feb 7, 2020
Last Update Posted:
Feb 3, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Delphinus Medical Technologies, Inc.

Study Results

No Results Posted as of Feb 3, 2021