Lisa Bey-Knight

Breast imaging with the SoftVue imaging system: first results

For women with dense breast tissue, who are at much higher risk for developing breast cancer, the performance of mammography is at its worst. Consequently, many early cancers go undetected when they are the most treatable. Improved cancer detection for women with dense breasts would decrease the proportion of breast cancers diagnosed at later stages, which would significantly lower the mortality rate. The emergence of whole breast ultrasound provides good performance for women with dense breast tissue, and may eliminate the current trade-off between the cost effectiveness of mammography and the imaging performance of more expensive systems such as magnetic resonance imaging. We report on the performance of SoftVue, a whole breast ultrasound imaging system, based on the principles of ultrasound tomography. SoftVue was developed by Delphinus Medical Technologies and builds on an early prototype developed at the Karmanos Cancer Institute. We present results from preliminary testing of the SoftVue system, performed both in the lab and in the clinic. These tests aimed to validate the expected improvements in image performance. Initial qualitative analyses showed major improvements in image quality, thereby validating the new imaging system design. Specifically, SoftVue’s imaging performance was consistent across all breast density categories and had much better resolution and contrast. The implications of these results for clinical breast imaging are discussed and future work is described.

Detection and characterization of breast masses with ultrasound tomography: Clinical results

We report on a continuing assessment of the in-vivo performance of an operator independent breast imaging device based on the principles of acoustic tomography. This study highlights the feasibility of mass characterization using criteria derived from reflection, sound speed and attenuation imaging. The data were collected with a clinical prototype at the Karmanos Cancer Institute in Detroit MI from patients recruited at our breast center. Tomographic sets of images were constructed from the data and used to form 3-D image stacks corresponding to the volume of the breast. Masses were identified independently by either ultrasound or biopsy and their locations determined from conventional mammography and ultrasound exams. The nature of the mass and its location were used to assess the feasibility of our prototype to detect and characterize masses in a case-following scenario. Our techniques generated whole breast reflection images as well as images of the acoustic parameters of sound speed and attenuation. The combination of these images reveals major breast anatomy, including fat, parenchyma, fibrous stroma and masses. The three types of images are intrinsically co-registered because the reconstructions are performed using a common data set acquired by the prototype. Fusion imaging, utilizing thresholding, is shown to visualize mass characterization and facilitates separation of cancer from benign masses. These initial results indicate that operatorindependent whole-breast imaging and the detection and a characterization of cancerous breast masses are feasible using acoustic tomography techniques.

Breast ultrasound tomography: bridging the gap to clinical practice

Conventional sonography, which performs well in dense breast tissue and is comfortable and radiation-free, is not practical for screening because of its operator dependence and the time needed to scan the whole breast. While magnetic resonance imaging (MRI) can significantly improve on these limitations, it is also not practical because it has long been prohibitively expensive for routine use. There is therefore a need for an alternative breast imaging method that obviates the constraints of these standard imaging modalities. The lack of such an alternative is a barrier to dramatically impacting mortality (about 45,000 women in the US per year) and morbidity from breast cancer because, currently, there is a trade-off between the cost effectiveness of mammography and sonography on the one hand and the imaging accuracy of MRI on the other. This paper presents a progress report on our long term goal to eliminate this trade-off and thereby improve breast cancer survival rates and decrease unnecessary biopsies through the introduction of safe, cost-effective, operatorindependent sonography that can rival MRI in accuracy. The objective of the study described in this paper was to design and build an improved ultrasound tomography (UST) scanner in support of our goals. To that end, we report on a design that builds on our current research prototype. The design of the new scanner is based on a comparison of the capabilities of our existing prototype and the performance needed for clinical efficacy. The performance gap was quantified by using clinical studies to establish the baseline performance of the research prototype, and using known MRI capabilities to establish the required performance. Simulation software was used to determine the basic operating characteristics of an improved scanner that would provide the necessary performance. Design elements focused on transducer geometry, which in turn drove the data acquisition system and the image reconstruction engine specifications. The feasibility of UST established by our earlier work and that of other groups, forms the rationale for developing a UST system that has the potential to become a practical, low-cost device for breast cancer screening and diagnosis.

Breast Imaging with Ultrasound Tomography: Clinical Results at the Karmanos Cancer Institute

We report and discuss clinical breast imaging results obtained with operator independent ultrasound tomography. A series of in-vivo experiments were carried out using a recently upgraded clinical prototype based on the principles of ultrasound tomography. The in-vivo performance of the prototype was assessed by imaging patients at the Karmanos Cancer Institute. Our techniques successfully demonstrated in-vivo tomographic imaging of breast architecture in both reflection and transmission imaging modes. Masses as small as 6 mm in size were detected. These initial results indicate that operator- independent whole-breast imaging and the detection of cancerous breast masses are feasible using ultrasound tomography techniques. This approach has the potential to provide a low cost, non-invasive, and non-ionizing means of evaluating breast masses. Future work will concentrate on extending these results to larger trials.

Breast imaging with SoftVue: initial clinical evaluation

We describe the clinical performance of SoftVue, a breast imaging device based on the principles of ultrasound tomography. Participants were enrolled in an IRB-approved study at Wayne State University, Detroit, MI. The main research findings indicate that SoftVue is able to image the whole uncompressed breast up to cup size H. Masses can be imaged in even the densest breasts with the ability to discern margins and mass shapes. Additionally, it is demonstrated that multi-focal disease can also be imaged. The system was also tested in its research mode for additional imaging capabilities. These tests demonstrated the potential for generating tissue stiffness information for the entire breast using through-transmission data. This research capability differentiates SoftVue from the other whole breast systems on the market. It is also shown that MRI-like images can be generated using alternative processing of the echo data. Ongoing research is focused on validating and quantifying these findings in a larger sample of study participants and quantifying SoftVues ability to differentiate benign masses from cancer.

Relationship between breast sound speed and mammographic percent density

Despite some shortcomings, mammography is currently the standard of care for breast cancer screening and diagnosis. However, breast ultrasound tomography is a rapidly developing imaging modality that has the potential to overcome the drawbacks of mammography. It is known that women with high breast densities have a greater risk of developing breast cancer. Measuring breast density is accomplished through the use of mammographic percent density, defined as the ratio of fibroglandular to total breast area. Using an ultrasound tomography (UST) prototype, we created sound speed images of the patients breast, motivated by the fact that sound speed in a tissue is proportional to the density of the tissue. The purpose of this work is to compare the acoustic performance of the UST system with the measurement of mammographic percent density. A cohort of 251 patients was studied using both imaging modalities and the results suggest that the volume averaged breast sound speed is significantly related to mammographic percent density. The Spearman correlation coefficient was found to be 0.73 for the 175 film mammograms and 0.69 for the 76 digital mammograms obtained. Since sound speed measurements do not require ionizing radiation or physical compression, they have the potential to form the basis of a safe, more accurate surrogate marker of breast density.

Whole breast tissue characterization with ultrasound tomography

A number of clinical trials have shown that screening ultrasound, supplemental to mammography, detects additional cancers in women with dense breasts. However, labor intensity, operator dependence and high recall rates have limited adoption. This paper describes the use of ultrasound tomography for whole-breast tissue stiffness measurements as a first step toward addressing the issue of high recall rates. The validation of the technique using an anthropomorphic phantom is described. In-vivo applications are demonstrated on 13 breast masses, indicating that lesion stiffness correlates with lesion type as expected. Comparison of lesion stiffness measurements with standard elastography was available for 11 masses and showed a strong correlation between the 2 measures. It is concluded that ultrasound tomography can map out the 3 dimensional distribution of tissue stiffness over the whole breast. Such a capability is well suited for screening where additional characterization may improve the specificity of screening ultrasound, thereby lowering barriers to acceptance.

Breast imaging with ultrasound tomography: Initial results with SoftVue

The purpose of this paper is to describe the technical and clinical performance of SoftVue, a breast imaging device based on the principles of ultrasound tomography. We report on initial results from data acquired from 30 participants in a recently undertaken clinical study. Initial results suggest that SoftVue can accurately image the full range of breast anatomy, including both benign lesions and cancer. Ongoing research is focused on assessing SoftVues ability to differentiate benign masses from cancer.

Breast imaging with ultrasound tomography: a comparative study with MRI

The purpose of this study was to investigate the performance of an ultrasound tomography (UST) prototype relative to magnetic resonance (MR) for imaging overall breast anatomy and accentuating tumors relative to background tissue. The study was HIPAA compliant, approved by the Institutional Review Board, and performed after obtaining the requisite informed consent. Twenty-three patients were imaged with MR and the UST prototype. T1 weighted images with fat saturation, with and without gadolinium enhancement, were used to examine anatomical structures and tumors, while T2 weighted images were used to identify cysts. The UST scans generated sound speed, attenuation, and reflection images. A qualitative visual comparison of the MRI and UST images was then used to identify anatomical similarities. A more focused approach that involved a comparison of reported masses, lesion volumes, and breast density was used to quantify the findings from the visual assessment. Our acoustic tomography prototype imaged distributions of fibrous stroma, parenchyma, fatty tissues, and lesions in patterns similar to those seen in the MR images. The range of thresholds required to establish tumor volume equivalency between MRI and UST suggested that a universal threshold for isolating masses relative to background tissue is feasible with UST. UST has demonstrated the ability to visualize and characterize breast tissues in a manner comparable to MRI. Thresholding techniques accentuate masses relative to background anatomy, which may prove clinically useful for early cancer detection.

Breast imaging with acoustic tomography: a comparative study with MRI

The objective of this study is to investigate a potential low-cost-alternative to MRI, based on acoustic tomography. Using MRI as the gold standard, our goals are to assess the performance of acoustic tomography in (i) depicting normal breast anatomy, (ii) imaging cancerous lesions and (iii) accentuating lesions relative to background tissue using thresholding techniques. Fifteen patients were imaged with MRI and with an acoustic tomography prototype. A qualitative visual comparison of the MRI and prototype images was used to verify anatomical similarities. These similarities suggest that the prototype can image fibrous stroma, parenchyma and fatty tissues, with similar sensitivity to MRI. The prototype was also shown to be able to image masses but equivalency in mass sensitivity with MRI could not be established because of the small numbers of patients and the prototypes limited scanning range. The range of thresholds required to establish tumor volume equivalency suggests that a universal threshold for isolating masses relative to background tissue is possible with acoustic tomography. Thresholding techniques promise to accentuate masses relative to background anatomy which may prove clinically useful in potential screening applications. Future work will utilize larger trials to verify these preliminary conclusions.