Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)

Abnormal Breast Screening Clinical Trial

— DMT SV RRS3  

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: NCT04260620
• Other study ID #: DMT-2019.002
• Status: Completed
• Start date: February 8, 2020
• Est. completion date: March 3, 2020

Study information

• Verified date: February 2021
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 3, 2020
• Est. primary completion date: March 3, 2020
• 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

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	Delphinus Medical Technologies, Inc.	Novi	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Delphinus Medical Technologies, Inc.	Boston Biomedical 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