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CompletedN/A

Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)

NCT04260620 · DMT SV RRS3 · Delphinus Medical Technologies, Inc.

Closed to entry
Status
Not accepting participants
Not applicable
Phase
32
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • MRMC Analysis: ROC AUC

    Measured over 8 Weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

Not stated
Ages
All
Sex
Not accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
Delphinus Medical Technologies, Inc.NoviMichiganUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04260620 on ClinicalTrials.gov →

Last updated in the registry 2021-02-03. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in