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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of REAL IMAGING'S 3D Functional Metabolic Imaging and Risk Assessment (3D MIRA) System in Women at High Risk for Breast Cancer

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Woman has read, understood and signed the inform consent form Age: 20 years and older Women who are asymptomatic for breast cancer Proven carriers of deleterious BRCA1 or BRCA2 mutations Or Women that were found to have a lifetime risk of developing breast cancer greater or equal to 20% based on Tyrer-Cuzick, Gail or Clause risk models Women scheduled to undergo routine mammography and/or US or MRI screening Exclusion Criteria: Women who have had a mammography and/or ultrasound examination performed on the day of the study prior to MIRA scan Women who had a lumpectomy surgery Women who had undergone mastectomy and/or reconstruction Women who have undergone any type of breast surgery throughout the 6 months preceding the study Women who have had a breast biopsy performed throughout the 10 weeks preceding the study. Women who have a fever on the day of the MIRA imaging Women who are pregnant Women who are breast-feeding Women who had undergone breast reduction/augmentation

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women at high risk for breast cancer<br>Proven carriers of deleterious BRCA1 or BRCA2 mutations Or Women that were found to have a lifetime risk of developing breast cancer greater or equal to 20% based on Tyrer-Cuzick, Gail or Clause risk models. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of 3D MIRA as a breast imaging aid in women with a high risk of breast cancer |  | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test whether repetitive screening with 3D MIRA technology can provide information on the likelihood of developing breast cancer. |  | up to 36 months |