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

NCT03288792 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 435

Last updated 2019-05-03

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

RI8 device imaging

RI8 Device imaging for adjunctive detection of breast cancer

Sponsors & Collaborators

  • Real Imaging Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-15
Primary Completion
2019-04-09
Completion
2019-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03288792 on ClinicalTrials.gov