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Evaluation of Real Imaging's 3D Functional Metabolic Imaging and Risk Assessment (MIRA) System

NCT02155075 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2018-06-19

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.

The purpose of this clinical study is to assess the ability of this novel technology to detect breast cancer in women.

Conditions

Interventions

DEVICE

MIRA device imaging

MIRA device imaging for adjunctive detection of breast cancer. Arm 1 administarte result

Sponsors & Collaborators

  • Real Imaging Ltd.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • Israel

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 NCT02155075 on ClinicalTrials.gov