Clinical trial NCT04260620: Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)
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 Detection
Dense Breast Parenchyma
Benign Breast Findings
Normal Breast Screening
Abnormal Breast Screening
Keywords: Breast Screening
Breast Imaging
SoftVue
Mammography
Ultrasound
Reader Study
ROC AUC
Dense Breasts
Breast Density
Dense Breast Tissue
Breast Neoplasms
Lead sponsor: Delphinus Medical Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Chicago
name: Boston Biomedical Associates
First posted: 2020-02-07
Enrollment: 32
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 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

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 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.


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.

Primary outcomes:
measure: MRMC Analysis: ROC AUC
timeFrame: 8 Weeks
Secondary outcomes:
measure: Sensitivity and Specificity
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Novi
country: United States
facility: Delphinus Medical Technologies, Inc.
state: Michigan
Study officials:
affiliation: University of Chicago
name: Yulei Jiang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: