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Delphinus SoftVue™ ROC Reader Study (DMT SV RRS2)

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ClinicalTrials.gov Identifier: NCT03972605
Recruitment Status : Enrolling by invitation
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborators:
University of Chicago
Boston Biomedical Associates LLC
Reed Technical Associates, LLC
Information provided by (Responsible Party):
Delphinus Medical Technologies, Inc.

Brief 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.


Condition or disease Intervention/treatment
Breast Cancer Detection Dense Breast Parenchyma Benign Breast Findings Normal Breast Screening Abnormal Breast Screening Device: Reading of Automated Breast Ultrasound in conjunction with Screening Mammography

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Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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.
Estimated Study Start Date : June 8, 2019
Estimated Primary Completion Date : July 2, 2019
Estimated Study Completion Date : July 2, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.
    Other Name: Digital Screening Mammography with Adjunctive SoftVue Screening Whole Breast Ultrasound


Primary Outcome Measures :
  1. MRMC Analysis: ROC AUC [ Time Frame: 8 Weeks ]
    Area under the ROC curve (AUC)


Secondary Outcome Measures :
  1. Sensitivity and Specificity [ Time Frame: 8 Weeks ]
    True Positive Rate and True Negative Rate



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Readers will evaluate mammography and SoftVue images acquired at study entry from consented participants in protocol DMT-2015.001, and subsequently categorized into the following case types, in random order:

  • Cancer cases, confirmed by breast biopsy with at least one lesion determined to be malignant during participation
  • Non‐Cancer cases including, but not limited to benign cases, confirmed by breast biopsy with no lesions determined to be malignant, or normal/negative screening or diagnostic imaging during participation
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972605


Locations
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United States, Michigan
Cobo Center
Detroit, Michigan, United States, 48226
Sponsors and Collaborators
Delphinus Medical Technologies, Inc.
University of Chicago
Boston Biomedical Associates LLC
Reed Technical Associates, LLC
Investigators
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Principal Investigator: Yulei Jiang, Ph.D University of Chicago
Principal Investigator: Mary Ellen Giger, Ph.D Univeristy of Chicago

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Responsible Party: Delphinus Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03972605     History of Changes
Other Study ID Numbers: DMT-2019.001
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Delphinus Medical Technologies, Inc.:
Breast Screening
Breast Imaging
SoftVue
Mammography
Ultrasound
Reader Study
ROC AUC
Dense Breasts
Breast Density
Dense Breast Tissue
Breast Neoplasms
Additional relevant MeSH terms:
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Signs and Symptoms