Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-02 @ 12:08 PM
Study NCT ID:
NCT03288792
Status:
TERMINATED
Last Update Posted:
2019-05-03
First Post:
2017-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Evaluation of 3D Functional MIRA System in Women With Mammographically Dense Breasts
Sponsor:
Real Imaging Ltd.
Organization:
Study Overview
Official Title:
A Prospective Multicenter Evaluation of Three Dimensional Functional Metabolic and Risk Assessment System in Women With Mammographically Dense Breasts
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision, not safety related
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this image acquisition study is to compare, in a Reader Study, the RI8 system used in conjunction with a conventional mammography to mammography alone, and to determine whether the addition of supplementary RI8 result will improve ROC area under the curve. The study is prospective, multi-center, sequential, control trial with the woman serving as her own control. Women determined to have heterogeneously or extremely dense breast based on her previous mammogram and are undergoing routine screening mammography at one of the clinical sites assigned for this study will be eligible to join the study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: