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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.

Tracking Information
First Submitted Date May 31, 2019
First Posted Date June 3, 2019
Last Update Posted Date June 3, 2019
Estimated Study Start Date June 8, 2019
Estimated Primary Completion Date July 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 31, 2019)
MRMC Analysis: ROC AUC [ Time Frame: 8 Weeks ]
Area under the ROC curve (AUC)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 31, 2019)
Sensitivity and Specificity [ Time Frame: 8 Weeks ]
True Positive Rate and True Negative Rate
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Delphinus SoftVue™ ROC Reader Study
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.
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Breast Cancer Detection
  • Dense Breast Parenchyma
  • Benign Breast Findings
  • Normal Breast Screening
  • Abnormal 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.
Other Name: Digital Screening Mammography with Adjunctive SoftVue Screening Whole Breast Ultrasound
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 31, 2019)
32
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2, 2019
Estimated Primary Completion Date July 2, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03972605
Other Study ID Numbers DMT-2019.001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Delphinus Medical Technologies, Inc.
Study Sponsor Delphinus Medical Technologies, Inc.
Collaborators
  • University of Chicago
  • Boston Biomedical Associates LLC
  • Reed Technical Associates, LLC
Investigators
Principal Investigator: Yulei Jiang, Ph.D University of Chicago
Principal Investigator: Mary Ellen Giger, Ph.D Univeristy of Chicago
PRS Account Delphinus Medical Technologies, Inc.
Verification Date May 2019