Clinical trial NCT03698942: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Breast Neoplasms
Keywords: Breast Screening
Breast Imaging
SoftVue
Mammography
Ultrasound
Reader Study
ROC AUC
Breast Cancer Detection
Dense Breasts
Breast Density
Dense Breast Tissue
Dense Breast Parenchyma
Lead sponsor: Delphinus Medical Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Chicago
name: Biostatistics Consulting, LLC
name: Reed Technical Associates, LLC
First posted: 2018-10-09
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Readers will evaluate mammography and SoftVue images acquired at study entry 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

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: MRMC Analysis: ROC AUC
timeFrame: 8 Weeks
Secondary outcomes:
measure: Sensitivity and Specificity
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Yulei Jiang, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Univeristy of Chicago
name: Mary Ellen Giger, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: