Delphinus SoftVue™ ROC Reader Study

Abnormal Breast Screening Clinical Trial

— DMT SV RRS2  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03972605
• Other study ID #: DMT-2019.001
• Status: Completed
• Start date: June 8, 2019
• Est. completion date: July 2, 2019

Study information

• Verified date: January 2020
• Source: Delphinus Medical Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2, 2019
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Abnormal Breast Screening
• Benign Breast Findings
• Breast Cancer Detection
• Dense Breast Parenchyma
• Normal Breast Screening
• Signs and Symptoms

Intervention

Device:
• Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
Reader performance when SoftVue automated breast ultrasound (SV) and digital screening mammography (DM) are combined, compared to screening mammography alone.

Locations

Country	Name	City	State
United States	Cobo Center	Detroit	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
Delphinus Medical Technologies, Inc.	Boston Biomedical Associates LLC, Reed Technical Associates, LLC, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRMC Analysis: ROC AUC	Area under the ROC curve (AUC)	8 Weeks
Secondary	Sensitivity and Specificity	True Positive Rate and True Negative Rate	8 Weeks