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A Evaluation of 3D Functional MIRA System in Women With Mammographically Dense Breasts

Breast Cancer Clinical Trial

Official title:
A Prospective Multicenter Evaluation of Three Dimensional Functional Metabolic and Risk Assessment System in Women With Mammographically Dense Breasts

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03288792
Study type Interventional
Source Real Imaging Ltd.
Contact
Status Terminated
Phase N/A
Start date April 15, 2018
Completion date April 30, 2019
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