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

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 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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: MIRA device imaging


Participation Criteria
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Eligibility Criteria
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PHASE 1: INCLUSION CRITERIA Female Woman has read, understood and signed the inform consent form Age: 30 years and older A. Women who are scheduled to undergo routine Mammography and/or US and/or MRI screening OR B. Women summoned for breast biopsy following a suspicious finding in recent screening exam and was graded 4/5 on BI-RADS scale EXCLUSION CRITERIA: Women who have had a Mammography and/or US and/or MRI examination performed on the day of the study prior to MIRA scan Women who had undergone mastectomy and/or breast reconstruction Women who have had a breast biopsy performed throughout the 6 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 with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices in the chest area Women who are unable to read, understand and execute written informed consent Women who are currently undergoing chemotherapy and/or radiotherapy PHASE 2: ARM 1: INCLUSION CRITERIA Female Age: 30 years and older A. Asymptomatic women who are scheduled to undergo routine screening mammography or routine screening mammography and US Or B. Subjects scheduled for image-guided needle biopsy as a result of findings obtained during standard of care imaging modalities (mammography, ultrasound and/or MRI). 5. Women whose most recent prior mammogram was interpreted as heterogeneously dense (ACR BI-RADS Breast Density C) or extremely dense (ACR BI-RADS Breast Density D). EXCLUSION CRITERIA: Subjects who have had a Mammography and/or US and/or MRI examination performed on the day of the study prior to MIRA scan Subjects scheduled for a diagnostic mammography due to a suspicious lump Subjects who had undergone mastectomy and/or breast reconstruction Subjects who have undergone breast reduction or breast augmentation. Subjects who have large breast scar / breast deformation. Subjects who have significant existing breast trauma. Subjects who have undergone lumpectomy Subjects who have had a breast needle biopsy performed throughout the 6 weeks preceding the study Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices in the chest area Subjects with known Raynaud's Disease. Subjects who have a fever on the day of the MIRA imaging Subjects who are pregnant Subjects who are breast-feeding Subjects with known Mastitis Subjects who are currently undergoing chemotherapy and/or radiotherapy Subjects with contraindication to bilateral mammography or MRI. Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase. Subjects currently participating in another clinical study. Subjects who are unable to read, understand and execute written informed consent ARM 2: INCLUSION CRITERIA: Female Age: 30 years and older Asymptomatic women who are scheduled to undergo routine screening mammography or routine screening mammography and US EXCLUSION CRITERIA : Subjects who have had a Mammography examination performed on the day of the study prior to MIRA scan Subjects scheduled for a diagnostic mammography due to a suspicious lump Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study Subjects who have a fever on the day of the MIRA imaging Subjects who are pregnant Subjects who are breast-feeding Subjects with known Mastitis Subjects with known Raynaud's Disease. Subjects who are currently undergoing chemotherapy and/or radiotherapy Subjects with contraindication to bilateral mammography Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase. Subjects currently participating in another clinical study. Subjects who are unable to read, understand and execute written informed consent

Ages Eligible for Study
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Minimum Age: 30 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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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Testing phase (Phase II) Arm 1 - 180 participant will be enrolled for this arm. Participants will be enrolled to undergo MIRA device imaging. Following the MIRA device imaging procedure, the optimized risk model will assign a binary result to the participant. All participants will recive standart of care, participants with negative screening exams and a positive MIRA device imaging result will additionally undergo MRI. | Device: MIRA device imaging<br>* MIRA device imaging for adjunctive detection of breast cancer. Arm 1 administarte result<br>* Other names: Real imager 8 (RI8);|
| Experimental: Arm 2<br>Testing phase (Phase II) Arm 2 - 150 participant will be enrolled for this arm. Participants will be enrolled to undergo MIRA device imaging. Following the MIRA device imaging procedure all participants in arm 2 will be following standard of care, MIRA device imaging will NOT change their clinical path. | Device: MIRA device imaging<br>* MIRA device imaging for adjunctive detection of breast cancer. Arm 1 administarte result<br>* Other names: Real imager 8 (RI8);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sufficient number of cancer case and controls have been imaged | As this is a data collection study, end point will be reached when approximately 50 women with breast cancer and 100 healthy women (controls) are imaged by the device and sufficient for the comparison statistical analysis. | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast neoplasm, Breast implants, Mammography, Breast imaging, Imaging augmented breast