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Guided By Research

The science behind SoftVue™ is based on several years of ultrasound research conducted within technical and clinical domains.  The data has demonstrated the benefits this technology can bring to the challenges of finding breast disease at an early stage in dense breast tissue. 

Clinical Study Summary

The Delphinus Pivotal Retrospective Reader Study (DMT-2019.002) was an analysis of radiologist image interpretation performance utilizing prospectively collected patient data obtained from the Discover SoftVue Prospective Case Collection (PCC) (DMT-2015.001). The patient data utilized in the reader study was collected from a total of six PCC Registry clinical sites across the U.S. The retrospective analysis performed was an observational case-controlled, multi-reader, multi-case Receiver Operating Characteristic (ROC) study involving 32 Readers who were MQSA qualified radiologists with experience in breast image interpretation. The cases were comprised of bilateral full-field digital mammography [FFDM] and SoftVue (SV) screening imaging acquired from the same patient during the same screening interval. There were one hundred and forty (140) cases sampled for the reader study from a pool of asymptomatic female volunteers with BI-RADS c or d breast density. The reader study provided pivotal data on AUC improvement, sensitivity, and specificity of SoftVue as a screening tool in comparison with digital mammography. A complete summary of the reader study endpoint results is provided in the SoftVue Physician Labeling. Additional SoftVue published research is highlighted below. 




                    
 
                                                  

                        
 

                           

                        
    
                  
                                               
                    
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                            Using Whole Breast Ultrasound Tomography to Improve Breast Cancer Risk Assessment: 
     A Novel Risk Factor Based on the Quantitative Tissue Property of Sound Speed
                          
                      
                      
    
                        
    

    

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    Open Access
    

    

    J. Clin. Med. 2020, 9(2), 367; https://doi.org/10.3390/jcm9020367
    

    Abstract: Mammographic percent density (MPD) is an independent risk factor for developing breast cancer, but its inclusion in clinical risk models provides only modest improvements in individualized risk prediction, and MPD is not typically assessed in younger women because of ionizing radiation concerns. Previous studies have shown that tissue sound speed, derived from whole breast ultrasound tomography (UST), a non-ionizing modality, is a potential surrogate marker of breast density, but prior to this study, sound speed has not been directly linked to breast cancer risk. To that end, we explored the relation of sound speed and MPD with breast cancer risk in a case-control study, including 61 cases with recent breast cancer diagnoses and a comparison group of 165 women, frequency matched to cases on age, race, and menopausal status, and with a recent negative mammogram and no personal history of breast cancer. Multivariable odds ratios (ORs) and 95% confidence intervals (CIs) were estimated for the relation of quartiles of MPD and sound speed with breast cancer risk adjusted for matching factors. Elevated MPD was associated with increased breast cancer risk, although the trend did not reach statistical significance (OR per quartile = 1.27, 95% CI: 0.95, 1.70; ptrend = 0.10). In contrast, elevated sound speed was significantly associated with breast cancer risk in a dose–response fashion (OR per quartile = 1.83, 95% CI: 1.32, 2.54; ptrend = 0.0003). The OR trend for sound speed was statistically significantly different from that observed for MPD (p = 0.005). These findings suggest that whole breast sound speed may be more strongly associated with breast cancer risk than MPD and offer future opportunities for refining the magnitude and precision of risk associations in larger, population-based studies, including women younger than usual screening
    

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                            Determinants of the Reliability of Ultrasound Tomography 
     Sound Speed Estimates as a Surrogate for Volumetric Breast Density
                          
                      
                      
    
                        
    Med Phys. 2015 Oct; 42(10): 5671–5678.
    

    Published online 2015 Sep 8. doi:  10.1118/1.4929985
    

     
    

    Selection of starting breast tissue image slice from the first four tomograms, which borders the chest wall. In this example, slice three was chosen to be the first slice without any chest wall present. Slices three and four were included in the final.
    Selection of starting breast tissue image slice from the first four tomograms, which borders the chest wall. In this example, slice three was chosen to be the first slice without any chest wall present. Slices three and four were included in the final.
    

    PURPOSE:
    

    High breast density, as measured by mammography, is associated with increased breast cancer risk, but standard methods of assessment have limitations including 2D representation of breast tissue, distortion due to breast compression, and use of ionizing radiation. Ultrasound tomography (UST) is a novel imaging method that averts these limitations and uses sound speed measures rather than x-ray imaging to estimate breast density. The authors evaluated the reproducibility of measures of speed of sound and changes in this parameter using UST.
    

     
    

     
    

    Depiction of the segmentation algorithm that was utilized to remove sections of each image associated with the water bath: (left) in this example using a midsection slice, the breast/water bath.
    Depiction of the segmentation algorithm that was utilized to remove sections of each image associated with the water bath: (left) in this example using a midsection slice, the breast/water bath.
    

    METHODS: 
    

    One experienced and five newly trained raters measured sound speed in serial UST scans for 22 women (two scans per person) to assess inter-rater reliability. Intrarater reliability was assessed for four raters. A random effects model was used to calculate the percent variation in sound speed and change in sound speed attributable to subject, scan, rater, and repeat reads. The authors estimated the intraclass correlation coefficients (ICCs) for these measures based on data from the authors’ experienced rater.
    

     
    

     
    

    RESULTS: 
    
    Median (range) time between baseline and follow-up UST scans was five (1-13) months. Contributions of factors to sound speed variance were differences between subjects (86.0%), baseline versus follow-up scans (7.5%), inter-rater evaluations (1.1%), and intrarater reproducibility (∼0%). When evaluating change in sound speed between scans, 2.7% and ∼0% of variation were attributed to inter- and intrarater variation, respectively. For the experienced rater’s repeat reads, agreement for sound speed was excellent (ICC = 93.4%) and for change in sound speed substantial (ICC = 70.4%), indicating very good reproducibility of these measures.
    

     
    

     
    

    Scatterplot of baseline and follow-up sound speed measures for each participant as measured by the experienced rater (N = 22).
    Scatterplot of baseline and follow-up sound speed measures for each participant as measured by the experienced rater (N = 22).
    

    CONCLUSIONS:
    

    UST provided highly reproducible sound speed measurements, which reflect breast density, suggesting that UST has utility in sensitively assessing change in density.
    

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                            Breast Density Measurements 
     Using Ultrasound Tomography For Patients Undergoing Tamoxifen Treatment
                          
                      
                      
    
                        
    Published online 2013 Feb 9. doi:  10.1117/12.2007146
    
    PMCID: PMC4241344 
    
NIHMSID: NIHMS618425
    

     
    

    Plots of the average change in sound speed measured using all separate measures of sound speed for patients that showed at least a 1 m/s decrease who had two UST scans (Left, n = 8) and three UST scans (Right, n = 7).
    Plots of the average change in sound speed measured using all separate measures of sound speed for patients that showed at least a 1 m/s decrease who had two UST scans (Left, n = 8) and three UST scans (Right, n = 7).
    

    Women with high breast density have an increased risk of developing breast cancer. Women treated with the selective estrogen receptor modulator tamoxifen for estrogen receptor positive breast cancer experience a 50% reduction in risk of contralateral breast cancer and overall reduction of similar magnitude has been identified among high-risk women receiving the drug for prevention. Tamoxifen has been shown to reduce mammographic density, and in the IBIS-1 chemoprevention trial, risk reduction and decline in density were significantly associated. Ultrasound tomography (UST) is an imaging modality that can create tomographic sound speed images of the breast.
    

     
    

    article_02_img_01These sound speed images are useful because breast density is proportional to sound speed. The aim of this work is to examine the relationship between UST-measured breast density and the use of tamoxifen. So far, preliminary results for a small number of patients have been observed and are promising. Correlations between the UST-measured density and mammographic density are strong and positive, while relationships between UST density with some patient specific risk factors behave as expected. Initial results of UST examinations of tamoxifen treated patients show that approximately 45% of the patients have a decrease in density in the contralateral breast after only several months of treatment.
    

     
    

     
    

    Average Sound Speed of Patients Showing a Decrease in Sound Speed. WVSS – whole volume sound speed; CVSS – common volume sound speed; DRWVSS – donut removed whole volume sound speed; DRCVSS – donut removed common volume sound speed
    Average Sound Speed of Patients Showing a Decrease in Sound Speed. WVSS – whole volume sound speed; CVSS – common volume sound speed; DRWVSS – donut removed whole volume sound speed; DRCVSS – donut removed common volume sound speed
    

    The true effect of tamoxifen on UST-measured density cannot yet be fully determined until more data are collected. However, these promising results suggest that UST can be used to reliably assess quantitative changes in breast density over short intervals and therefore suggest that UST may enable rapid assessment of density changes associated with therapeutic and preventative interventions.
    

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                            Using Speed of Sound Imaging 
     To Characterize Breast Density
                          
                      
                      
    
                        
    Published online Ultrasound Med Biol. 2016 Sep 29. doi: 10.1016/j.ultrasmedbio.2016.08.021.
    

    A population of 165 women with negative mammographic screens also received an ultrasound tomography (UST) examination at the Karmanos Cancer Institute in Detroit, MI. Standard statistical techniques were employed to measure the associations between the various mammographic- and UST-related density measures and various participant characteristics such as age, weight and height. The mammographic percent density (MPD) was found to have similar strength associations with UST mean sound speed (Spearman coefficient, rs = 0.722, p < 0.001) and UST median sound speed (rs = 0.737, p < 0.001). Both were stronger than the associations between MPD with two separate measures of UST percent density, a k-means (rs = 0.568, p < 0.001) or a threshold (rs = 0.715, p < 0.001) measure. Segmentation of the UST sound speed images into dense and non-dense volumes showed weak to moderate associations with the mammographically equivalent measures. Relationships were found to be inversely and weakly associated between age and the UST mean sound speed (rs = -0.239, p = 0.002), UST median sound speed (rs = -0.226, p = 0.004) and MPD (rs = -0.204, p = 0.008). Relationships were found to be inversely and moderately associated between body mass index (BMI) and the UST mean sound speed (rs = -0.429, p < 0.001), UST median sound speed (rs = -0.447, p < 0.001) and MPD (rs = -0.489, p < 0.001). The results confirm and strengthen findings presented in previous work indicating that UST sound speed imaging yields viable markers of breast density in a manner consistent with mammography, the current clinical standard. These results lay the groundwork for further studies to assess the role of sound speed imaging in risk prediction.
    

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