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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03698942
Other study ID # DMT-2015.002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 23, 2018
Est. completion date September 23, 2018

Study information

Verified date February 2020
Source Delphinus Medical Technologies, Inc.
Contact n/a
Is FDA regulated No
Health authority
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 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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date September 23, 2018
Est. primary completion date September 23, 2018
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 Inclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


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 University of Chicago Chicago Illinois

Sponsors (4)

Lead Sponsor Collaborator
Delphinus Medical Technologies, Inc. Biostatistics Consulting, 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
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