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

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.

Sex

Female

Minimum age

30 Years

Maximum age

80 Years

Inclusion Criteria:

* Female
* Woman has read, understood and signed the inform consent form
* Age: 30 years and older
* Women who are asymptomatic and are scheduled to undergo routine Mx and/or US screening OR Women summoned for breast biopsy following a suspicious finding in recent screening exam and was graded 4/5/6 on BI-RADS scale

Exclusion Criteria:

* Women who have had a Mx (mammography) and/or US and/or MRI examination performed on the day of the study prior to MIRA scan
* Women who had a lumpectomy surgery preceding the study
* Women who had undergone mastectomy and/or breast reconstruction
* Women who have undergone any type of breast surgery 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 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 have had chemotherapy and/or radiotherapy throughout the 6 months preceding the study