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Spots Global Cancer Trial Database for Evaluation of Real Imaging's 3D Functional Metabolic Imaging and Risk Assessment (MIRA) System

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Trial Identification

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

Official Title: Evaluation of Real Imaging's 3d Functional Metabolic Imaging and Risk Assessment (Mira) System

Study ID: NCT02155075

Conditions

Breast Cancer

Interventions

MIRA device imaging

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 30 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

The Chaim Sheba Medical Center at Tel Hashomer, Ramat-Gan, , Israel

Contact Details

Name: Miri Sklair-Levy, MD

Affiliation: The Chaim Sheba Medical center at Tel-Hashomer

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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