Research Validates Value of Volpara Solutions’ Volumetric Breast Density and Analytics Data to Help Maintain Accuracy and Consistent Quality in Breast Screening

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Eight Abstracts Accepted for Presentation at ECR Demonstrate Ability to Track Temporal Changes in Breast Density and Improve Mammographic Compression and Positioning

The ability of Volpara Solutions’ volumetric breast density and analytics data to help maintain accuracy and consistent quality in breast screening is the focus of numerous abstracts accepted for presentation at the European Congress of Radiology (ECR) meeting, March 2-6, 2016. (Booth #623). Eight studies – six posters and two oral presentations – highlight the use of Volpara's automated breast density and quantitative breast imaging software tools to provide breast density results correlated to the 4th and 5th Editions of the BI-RADS Atlas, to monitor temporal changes in breast density, and improve mammographic compression and positioning.

Breast density is associated with increased risk in BRCA carriers; however, the relationship between oopherectomy and breast density and which method of breast density interpretation is best for temporal change has not been investigated. In the presentation, “Decrease of breast density in BRCA patients following oophorectomy using Volpara software,” (SS 1502) researchers from the Institut Gustave Roussy in Paris used VolparaDensity and visual assessment by radiologists to track changes in mammographic breast density in 50 BRCA positive patients undergoing risk reducing oophorectomy surgery. The study found a significant decrease in volumetric breast density following surgery and the degree of change was larger in younger patients. Using the Volpara Density Grades categories (VDG; analogous to BI-RADS density categories), 84% of women displayed a decrease in density category over the study period compared to only 76% using the visual BI-RADS classification. These results suggest that VolparaDensity is more sensitive to temporal changes in breast density over time compared to visual assessment.

In the scientific exhibit, “Optimizing VolparaDensity’s volumetric breast density thresholds to align with the ACR BIRADS 5th edition updates” (#4745), Volpara conducted a reader study to evaluate whether the cutoffs used by VolparaDensity to assign automated BI-RADS density categories needed to be updated to reflect changes made in the 5th edition lexicon. In the study, 294 mammographic studies were read by five experienced U.S. radiologists using the updated 5th edition definitions and compared to the 4th edition Volpara Density Grades and found an agreement of 75% (kw 0.792) with the median radiologist score. By using the maximum volumetric breast density and altering the threshold between VDG1 and 2, the agreement with radiologists was improved to 79% (kw 0.816). Based on this data, the U.S. FDA recently awarded a 510(k) clearance for VolparaDensity to provide breast density results correlated to the 4th and 5th Editions of the BI-RADS Atlas.

According to European guidelines, breast compression during mammography should be firm but tolerable. However, the lack of consistent compression guidelines has led to wide variation in execution. The aim of the study “Real-time pressure indicator makes mammographic breast compression more reproducible than a rule of thumb,” was to investigate the influence of compression protocols on mechanical parameters. Researchers from the Academic Medical Center in Amsterdam used VolparaAnalytics to assess the impact of different breast compression protocols on changes in applied force, pressure and breast contact area. The results demonstrated that a pressure-guided protocol using a compression paddle with a real time pressure indicator resulted in a reduction in force and pressure and more consistency between patients.

Mammographic breast positioning is crucial for clinical interpretation but is time consuming and subjective to assess. In the scientific exhibit, “A validation study of automated mammographic breast positioning metrics,” (#4755) Volpara evaluated the performance of a novel algorithm for the automatic assessment of four breast positioning metrics from digital mammograms, comparing to a visual ground truth analysis. Volpara Density Maps was used to evaluate the positioning metrics of nipple location and nipple in profile, nipple angle on the CC view and whether the inframammary fold (IMF) was present on the MLO in more than 700 images. The detection of the nipple location was excellent with agreement within 10mm in 99.4% of the cases. The performance of the algorithm to detect the nipple in profile, if IMF was visible and the correct nipple direction was very good with 85%, 88% and 73% agreement respectively, with ground truth assessment. Overall the automated positioning algorithm was highly robust and has the potential to improve the efficiency of assessing mammographic breast positioning.

EuroSafe Imaging is the ESR’s latest initiative in radiation protection, which aims to promote the safe and appropriate use of medical imaging in Europe and around the world. Volpara Solutions is presenting a poster, “Real-Time Mammography Dose Monitoring and Optimisation using Big Data” (ESI-0033) outlining the new potential to use big data analytics to optimise dose and evolve dose monitoring beyond the use of phantoms and diagnostic reference levels. Using Volpara’s suite of quantitative breast imaging tools, users can accurately measure the actual dose delivered to the glandular tissue of the individual women’s breast. Computing and presenting the dose for every women imaged within a screening programme using VolparaEnterprise, allows optimisation of dose monitoring and facilities relative comparison across the programme, resulting in easy outlier analysis to identify subtle discrepancies between machines.

The following scientific exhibits feature Volpara technology:

  •     The impact of mammographic quality control on breast density was studied by Norwegian researchers in the presentation, “Error in recorded compressed breast thickness measurement impacts on volumetric density classification,” (B-1119). Researchers conclude that good mammographic QC is important to acquire accurate breast density results.
  •     “Comparison of subjective breast density categorisation vs VOLPARA software” (C-2275); Researchers from University College Dublin assessed the agreement between US and UK radiologists in visual assessment of density and compared to VolapraDensity. Overall there was a higher agreement between Volpara and US radiologists than UK radiologists indicative of Volpara being trained to match US radiologists.
  •     “Measuring mammographic density: Comparing a fully automated volumetric assessment versus European radiologists' qualitative classification” (C-0383); Examinations from the Malmo Breast Tomo Screening Trial were used for a reader study comparing visual assessment of breast density with Volpara. The researchers propose adjusting the Volpara thresholds for European populations may improve agreement.

“The results of the IGR study, demonstrating the ability of VolparaDensity to monitor temporal changes in breast density, add to the growing portfolio of scientific evidence supporting the ability of volumetric breast density to improve breast screening,” said Ralph Highnam, Ph.D., CEO and Chief Scientist of Volpara Solutions. “We are proud that this year’s ECR programme also features several studies demonstrating that VolparaAnalytics is an integral component to the standardization of mammographic compression and positioning. This has tremendous opportunity to improve quality control in mammography and patient experience by eliminating technical variability.”

Cleared by the FDA, HealthCanada, the TGA and CE-marked, VolparaDensity is in use at breast imaging centers worldwide to help radiologists objectively assess density from digital mammography and tomosynthesis images to determine which women might benefit from additional imaging. Highly correlated to breast MR assessments, VolparaDensity is a reliable tool that automatically generates an objective measurement of volumetric breast density correlated to the 4th and 5th Editions of the BI-RADS Atlas from the ACR. Volpara Solutions technology is currently in use in 33 countries, and more than 7 million women have had their breast density analyzed using VolparaDensity.

About Volpara Solutions
Founded with the goal of helping radiologists give women the most accurate information possible regarding their breast health, Volpara Solutions is the wholly owned sales and marketing arm of Volpara Health Technologies Limited of New Zealand (formerly Matakina Technology). CE-marked and cleared by the FDA, Health Canada, and the TGA, VolparaDensity provides an objective volumetric measure of breast density from both digital mammography and tomosynthesis data. VolparaDensity is part of a suite of quantitative breast imaging tools built on the Volpara Solutions algorithm that allows for personalized measurements of density, patient-specific x-ray dose, breast compression, breast positioning, and other factors designed to provide critical insight for breast imaging workflow. For more information, visit
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