Delphinus SoftVue™ ROC Reader Study | NCT03698942

Studies
Delphinus SoftVue™ ROC Reader Study

NCT03698942

Sponsor

Delphinus Medical Technologies, Inc.

Status

Completed

Last Update Posted

Feb 7, 2020Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Breast Cancer
Breast Neoplasms

Interventions

Reading of Automated Breast Ultrasound in conjunction with Screening Mammography

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 23, 2018Actual

Primary Completion Date

Sep 23, 2018Actual

Completion Date

Sep 23, 2018Actual

First Submitted Date

Aug 13, 2018

First Submission Date that Met QC Criteria

Oct 5, 2018

First Posted Date

Oct 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2020

Last Update Posted Date

Feb 7, 2020Actual

Name	Class
University of Chicago	OTHER
Biostatistics Consulting, LLC	UNKNOWN
Reed Technical Associates, LLC	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reading of Automated Breast Ultrasound in conjunction with Screening Mammography	Device	Reader performance when SoftVue automated breast ultrasound (SV) and digital screening mammography (DM) are combined, compared to screening mammography alone.		Digital Screening Mammography with SoftVue Supplemental Screening Whole Breast Ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MRMC Analysis: ROC AUC	Area under the ROC curve (AUC)	8 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Sensitivity and Specificity	True Positive Rate and True Negative Rate	8 Weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yulei Jiang, Ph.D	University of Chicago	Principal Investigator
Mary Ellen Giger, Ph.D	Univeristy of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago		Chicago	Illinois	60637	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases