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Although mammography is the gold standard for breast imaging, its limitations result in a high rate of biopsies of benign lesions and a significant false negative rate for women with dense breasts. In response to this imaging performance gap we have been developing a clinical breast imaging methodology based on the principles of ultrasound tomography. The Computed Ultrasound Risk Evaluation (CURE) system has been designed with the clinical goals of whole breast, operator-independent imaging, and differentiation of breast masses. This paper describes the first clinical prototype, summarizes our initial image reconstruction techniques, and presents phantom and preliminary in vivo results. In an initial assessment of its in vivo performance, we have examined 50 women with the CURE prototype and obtained the following results. (1) Tomographic imaging of breast architecture is demonstrated in both CURE modes of reflection and transmission imaging. (2) In-plane spatial resolution of 0.5 mm in reflection and 4 mm in transmission is achieved. (3) Masses > 15 mm in size are routinely detected. (4) Reflection, sound speed, and attenuation imaging of breast masses are demonstrated. These initial results indicate that operator-independent, whole-breast imaging and the detection of breast masses are feasible. Future studies will focus on improved detection and differentiation of masses in support of our long-term goal of increasing the specificity of breast exams, thereby reducing the number of biopsies of benign masses.

Although mammography is the gold standard for breast imaging, its limitations result in a high rate of biopsies of benign lesions and a significant false negative rate for women with dense breasts. In response to this imaging performance gap we have been developing a clinical breast imaging methodology based on the principles of ultrasound tomography. The Computed Ultrasound Risk Evaluation (CURE) system has been designed with the clinical goals of whole breast, operator-independent imaging, and differentiation of breast masses. This paper describes the first clinical prototype, summarizes our initial image reconstruction techniques, and presents phantom and preliminary in vivo results. In an initial assessment of its in vivo performance, we have examined 50 women with the CURE prototype and obtained the following results. (1) Tomographic imaging of breast architecture is demonstrated in both CURE modes of reflection and transmission imaging. (2) In-plane spatial resolution of 0.5 mm in reflection and 4 mm in transmission is achieved. (3) Masses15 mm in size are routinely detected. (4) Reflection, sound speed, and attenuation imaging of breast masses are demonstrated. These initial results indicate that operator-independent, whole-breast imaging and the detection of breast masses are feasible. Future studies will focus on improved detection and differentiation of masses in support of our long-term goal of increasing the specificity of breast exams, thereby reducing the number of biopsies of benign masses.

The Karmanos Cancer Institute has developed an ultrasound (US) tomography system, known as Computerized Ultrasound Risk Evaluation (CURE), for detecting and evaluating breast cancer, with the eventual goal of providing improved differentiation of benign masses from cancer. We report on our first clinical findings with CURE.

Ultrasound imaging is widely used in medicine because of its benign characteristics and real-time capabilities. Physics theory suggests that the application of tomographic techniques may allow ultrasound imaging to reach its full potential as a diagnostic tool allowing it to compete with other tomographic modalities such as x-ray computer tomography, and MRI. This paper describes the construction and use of a prototype tomographic scanner and reports on the feasibility of implementing tomographic theory in practice and the potential of ultrasound (US) tomography in diagnostic imaging. Data were collected with the prototype by scanning two types of phantoms and a cadaveric breast. A specialized suite of algorithms was developed and utilized to construct images of reflectivity and sound speed from the phantom data. The basic results can be summarized as follows. (i) A fast, clinically relevant US tomography scanner can be built using existing technology. (ii) The spatial resolution, deduced from images of reflectivity, is 0.4 mm. The demonstrated 10 cm depth-of-field is superior to that of conventional ultrasound and the image contrast is improved through the reduction of speckle noise and overall lowering of the noise floor. (iii) Images of acoustic properties such as sound speed suggest that it is possible to measure variations in the sound speed of 5 m/s. An apparent correlation with x-ray attenuation suggests that the sound speed can be used to discriminate between various types of soft tissue. (iv) Ultrasound tomography has the potential to improve diagnostic imaging in relation to breast cancer detection.

The Karmanos Cancer Institute is developing an ultrasound device for measuring and imaging acoustic parameters of human tissue. This paper discusses the experimental results relating to tomographic reconstructions of phantoms and tissue. The specimens were scanned by the prototype scanner at a frequency of 1.5 MHz using 2 microsecond pulses. The receivers and transmitters were positioned along a ring trajectory having a diameter of 20 cm. The ring plane is translated in the vertical direction allowing for 3-D reconstructions from stacked 2-D planes of data. All ultrasound scans were performed at 10 millimeter slice thickness to generate multiple tomographic images. In a previous SPIE paper we presented preliminary results of ultrasound tomographic reconstruction of formalin-fixed breast tissue. We now present new results from data acquired with the scanner. Images were constructed using both reflection-based and transmission based algorithms. The resulting images demonstrate the ability to detect sub-mm features and to measure acoustic properties such as sound speed. Comparison with conventional ultrasound indicates the potential for better margin definition and acoustic characterization of tissue.

New ultrasound data, obtained with a circular experimental scanner, are compared with data obtained with standard X-ray CT. Ultrasound data obtained by scanning fixed breast tissue were used to generate images of sound speed and reflectivity. The ultrasound images exhibit approximately 1 mm resolution and about 20 dB of dynamic range. All data were obtained in a circular geometry. X-ray CT scans were used to generate X-ray images corresponding to the same 'slices' obtained with the ultrasound scanner. The good match of sensitivity, resolution and angular coverage between the ultrasound and X-ray data makes possible a direct comparison of the three types of images. We present the results of such a comparison for an excised breast fixed in formalin. The results are presented visually using various types of data fusion. A general correspondence between the sound speed, reflectivity and X-ray morphologies is found. The degree to which data fusion can help characterize tissue is assessed by examining the quantitative correlations between the ultrasound and X-ray images.

In contrast to standard reflection ultrasound (US), transmission US holds the promise of more thorough tissue characterization by generating quantitative acoustic parameters. We compare results from a conventional US scanner with data acquired using an experimental circular scanner operating at frequencies of 0.3 - 1.5 MHz. Data were obtained on phantoms and a normal, formalin-fixed, excised breast. Both reflection and transmission-based algorithms were used to generate images of reflectivity, sound speed and attenuation.. Images of the phantoms demonstrate the ability to detect sub-mm features and quantify acoustic properties such as sound speed and attenuation. The human breast specimen showed full field evaluation, improved penetration and tissue definition. Comparison with conventional US indicates the potential for better margin definition and acoustic characterization of masses, particularly in the complex scattering environments of human breast tissue. The use of morphology, in the context of reflectivity, sound speed and attenuation, for characterizing tissue, is discussed.

Our Computerized Ultrasound Risk Evaluation (CURE) system has been developed to the engineering prototype stage and generated unique data sets of both transmission and reflection ultrasound (US). This paper will help define the clinical underpinnings of the developmental process and interpret the imaging results from a similar perspective. The CURE project was designed to incorporate numerous diagnostic parameters to improve upon two major areas of early breast cancer detection. CURE may provide improved tissue characterization of breast masses and reliable detection of abnormal microcalcifications found in some breast cancers and ductal carcinoma in situ (DCIS). Current breast US is limited to mass evaluation, whereas mammography also detects and guides biopsy of malignant calcifications. Screening with CURE remains a distant goal, but improved follow-up of mammographic abnormalities may represent a feasible breakthrough.

A method and system for examining tissue are provided in which the tissue is maintained in a position so that it may be insonified with a plurality of pulsed spherical or cylindrical acoustic waves. The insonifying acoustic waves are scattered by the tissue so that scattered acoustic radiation including a mix of reflected and transmitted acoustic waves is received. A representation of a portion of the tissue is then derived from the received scattered acoustic radiation.

Although mammography is the gold standard for breast imaging, it leads to a high rate of biopsies of benign lesions and a significant false negative rate for women with dense breasts. A clinical breast‐imaging device, based on the principles of ultrasound tomography, is being developed in response to this imaging performance gap. The computed ultrasound risk evaluation (CURE) system has been designed with the clinical goal of providing fast, whole‐breast, operator‐independent imaging, capable of differentiating breast masses. In an initial assessment of its in vivo performance, 50 patients were examined with CURE. The following results were demonstrated: (i) tomographic imaging of breast architecture, (ii) in‐plane spatial resolution of 0.5 mm in reflection and 4 mm in transmission, (iii) imaging of breast masses in reflection and transmission mode (sound speed and attenuation, and (iv) differentiation of breast masses was shown to be feasible. These initial results indicate that operator‐independent, whole‐breast imaging and the detection and characterization of breast masses are feasible. Future studies will focus on improved detection and differentiation of masses with the long‐term goal of improving the specificity of breast exams. [The authors acknowledge financial support from the Karmanos Cancer Institute and the NIH (grant R43 CA108072‐01).]