Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT04260620
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2020-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)
Sponsor:
Delphinus Medical Technologies, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DMT SV RRS3
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: