Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
32 participants
OBSERVATIONAL
2020-02-08
2020-03-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
ALL
No
Sponsors
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University of Chicago
OTHER
Boston Biomedical Associates
OTHER
Delphinus Medical Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yulei Jiang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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Delphinus Medical Technologies, Inc.
Novi, Michigan, United States
Countries
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Other Identifiers
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DMT-2019.002
Identifier Type: -
Identifier Source: org_study_id
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