iReveal® is designed for radiologists reading mammography who want to standardize the assessment and reporting of breast density. iReveal helps radiologists and radiology professionals identify patients whose dense breast tissue may impact the ability of the mammogram to clearly identify potentially concerning lesions and those who may benefit from supplemental screening or surveillance protocols. iReveal uses an “appearance-based” approach to assess breast structure, texture, and fibroglandular dispersion to simulate the process radiologists use to measure breast density, and provide automated, rapid, and reproducible breast density results.
Clinical Relevance of Automated Breast Density
Mammography is considered to be the gold standard in breast cancer screening. However, mammography has been proven to be less effective in women with dense breast tissue. There is also growing evidence that a higher percentage of dense breast tissue increases the risk of developing breast cancer.
Breast Density Statistics
iReveal is designed to detect dense breast tissue present in a mammogram. iReveal identifies the risk of potentially masking a cancer, then maps the percentage of the fibroglandular tissue to a density category corresponding to the BI-RADS standards.
Clinical Support Decision Scorecard
Advanced Breast Density Algorithm
The iReveal algorithm adopts a methodology that considers both distribution and dispersion of fibroglandular tissue aligning iReveal’s breast density measurement directly to the new BI-RADS standard of identifying dense tissue in the breast that could be masking cancer. The masking risk is correlated to the amount and also the distribution of fibroglandular tissue.
In the figure above, the focally dense structure in Breast 2 is more likely to hide a cancerous lesion by reducing the ability to visualize details and fine structures that could be a sign of a malignant abnormality. In this example, dispersion, in combination with percent breast density, best depicts results consistent with an expert radiologist’s interpretation of breast density.
In a clinical study, iReveal was shown to have statistical agreement with a panel of 10 expert radiologists specializing in breast imaging when assessing the percentage of breast density of over 500 mammography cases. The radiologists’ results were used to align iReveal’s percentage of breast density to the BI-RADS breast density assessment categories. iReveal is an adjunctive breast density assessment that radiologists can trust.
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