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Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer.

NCT02009150 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 236

Last updated 2018-09-05

No results posted yet for this study

Summary

Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 4(RI4) developed by Real Imaging. This technology generates 3D metabolic maps and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor. The procedure is non-invasive, comfortable and does not involve ionizing radiation. Moreover, Real Imaging's 3D Functional MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts.

The purpose of this clinical study is to assess the ability of this novel technology to detect clinically occult breast cancer in a cohort of women that are at high risk for breast cancer.

We hypothesize that the combination of screening mammography and metabolic screening (3D MIRA) will result in significantly higher breast cancer detection rates.

Conditions

Sponsors & Collaborators

  • Real Imaging Ltd.

    lead INDUSTRY

Principal Investigators

  • Miri Sklair-Levy, MD · The Chaim Sheba Medical center at Tel-Hashomer

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-07-31
Completion
2018-10-31

Countries

  • Israel

Study Locations

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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 NCT02009150 on ClinicalTrials.gov