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A Data Collection Study for the Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment

NCT02505698 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-04-11

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 8 (RI8) developed by Real Imaging. This technology generates 3D metabolic maps of the breast and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor in the breast. The procedure is non-invasive, comfortable and does not involve ionizing radiation. It is based on acquiring infrared images of the breast. Those images are processed and analyzed by computers to provide the objective risk assessment.

The technology is intended to be used as a screening tool for breast cancer and emerges as highly useful in women for whom screening mammography is sub-optimal, such as women with dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts.

Real Imaging is continuously developing the technology including image acquisition hardware and objective analysis of the imaging biomarkers. To further improve and optimize this novel metabolic imaging technology, Real Imaging will introduce an improved imaging device.

The purpose of this clinical study is to collect more imaging data in order to establish superiority of the newer device over the previous one.

The investigators hypothesize is that the new device will be at least as good as the previous one.

Conditions

Sponsors & Collaborators

  • Real Imaging Ltd.

    lead INDUSTRY

Principal Investigators

  • Orit Golan, MD · The Breast Imagning Unit at Tel Aviv Medical Center

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2015-10-31
Completion
2015-10-31

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 NCT02505698 on ClinicalTrials.gov