S6-1. Protocol and System setting for 2 nd generation Ultrasound Contrast Agent. 9 th US Contrast. (For diagnosis and navigation in treatments)

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1 S6-1 Protocol and System setting for 2 nd generation Ultrasound Contrast Agent (For diagnosis and navigation in treatments) Tsuyoshi Mitake Senior Chief Engineer Ultrasound System Division Hitachi Medical Corporation 1. Introduction In localized tumor of liver disease, the diagnostic imaging by using blood flow information is very important. It is advantage that the ultrasound examination can detect tumors without any contrast agent in Doppler and CFM. But for detailed differential diagnosis for detected tumor, contrast agents that are 1 st generation ultrasound contrast agent are sometimes very helpful. They give more information to diagnose. However, to use such agents, some complicated protocol and scanning procedure is needed compared with standard ultrasound examination. In addition, from the view point of giving more objectives, Computer Tomography (CT) is more popular in localized tumor of liver disease. In the past and now, after detecting the tumor, dynamic CT (contrast enhanced CT) is golden standard to diagnose. However, it is hard to make CT scanning frequently because of patients health and cost issue. To make diagnosis for the incidence of cancer in chronic liver diseases, the navigation during treatments and follow-up of treatment, some sort of non-invasive diagnosis method is required. Under such requirement, it seems 2 nd generation ultrasound contrast agents are more suitable to use in actual clinical situation because of simple protocol, simple scanning method and less Fig. 1 EUB-7500 invasive. To support such new imaging method, we have developed and optimized functions for the contract enhanced imaging by using 2 nd generation agent in mid-tier system (Fig. 1) not only high-end system. We would like to report some typical functionalities to use 2 nd generation agent in diagnosis and therapy supporting. 2. Functions for Contrast Enhanced Imaging in diagnosis Wideband Pulse Inversion In case the use of 2 nd generation contrast agent, it is necessary to decrease ultrasound transmitting power to avoid destroying bubbles. This sometimes causes the lack of penetration. To achieve the penetration and resolution, it is mandatory that the lower frequency component should be used for increasing penetration and the higher frequency component should be used for better resolution. Our Wideband Pulse Inversion can realize to depict better image by using the optimal mixture of low and high frequency component in the reflection signals. -66-

2 2.1. Alternate Mode In case of the usage of 2 nd generation contrast agent, the transmission power should be kept lower level. So, before the injection of the agent, the ultrasound image is difficult to observe by one of the reason that is less power. To find out the lesion before the injection in easier, we developed Alternate Mode which can display contrast enhanced image and fundamental gray scale image to solve this issue Flush bubble removing and MTI (Micro bubble Trace Imaging) To observing the process of perfusion more than once, it is needed to remove bubbles which are accumulated in Fig. 2 Alternate Mode organs. Flush bubble removing function have been Courtesy of Dr. Tanaka in Mie University developed for this purpose. Flush bubble removing function is transmitting ultrasound in high power and high rate to eliminate any bubbles. And Micro bubble imaging is holding high intensity signals in images. These functions are well-suited to observe blood vessel stricture. 3. Real-time Virtual Sonography with contrast agent We have developed a function named Real-time Virtual Sonography (RVS) which can display real time ultrasound image and Multi-planer Reconstruction image (MPR) of which cross-sectional plane is corresponding to the ultrasound scanning, simultaneously. CT volume data (MRI volume data is also available.) should be taken previously. Its system configuration is shown Fig. 3. (The external PC in the figure is already integrated into Ultrasound scanner now.) This feature is good tools to navigate Radio Frequency Ultrasound Scanner Probe Magnetic Sensor Magnetic field generator Detector unit PC Ablation (RFA). Some liver cancers are hard to see just only Fig. 3 System configuration for RVS in ultrasound image, so the observation of CT MPR image as reference is sometimes very helpful (fig. 4). And by displaying of both contrast enhanced ultrasound image and CT MPR image, we believe that it is much easier to confirm the location of lesion which should be made RFA. In addition, we developed Real-time Virtual Sonography by using ultrasound 3D volume date with/without contrast agent instead of CT volume data. Fig. 5 is US/US with contrast imaging, means that it is ultrasound image with contrast enhanced image and real time ultrasound image. It was taken at additional RFA to make coagulation in the residual portion. -67-

3 Fig. 4 RVS (CT MPR and real time ultrasound image) Courtesy of Dr. Iwasaki in Tohoku University 4. Conclusion Fig. 5 Courtesy of Dr. Kobayashi in Okayama University Some technologies are reported in the above. Technology looks moving very fast in not only medicine and engineering but also physics and pharmacy recently. We believe that we have to have tight collaboration among every party to keep progress in the healthcare. -68-

4 S6-2 Updated Imaging Techniques and Clinical Applications for New-Generation Contrast Agents Naohisa Kamiyama, Tetsuya Yoshida, Hiroyuki Ohuchi, and Tomohisa Imamura Toshiba Medical Systems Corporation 1. Introduction: New ultrasound contrast agents, commonly referred to as new-generation contrast agents, are now available in several countries (Europe, Canada, China, Japan, etc.). Although the commercially available contrast agents differ among these countries, they share certain similarities: they generate nonlinear signals when driven by ultrasound pulses with a very low mechanical index (MI) and they readily collapse when exposed to high-mi pulses. In this report, we describe the current contrast imaging mode of Aplio XG (Toshiba Medical Systems Corp.) and discuss the optimal imaging settings. We also present several new imaging techniques for new clinical applications. 2. Basic functions: In Pulse Subtraction (PS) mode, wideband harmonic echo amplitudes are used to create a grayscale image. The frequency is an important parameter for obtaining the optimal balance between the spatial resolution and penetration. The h3.0 (MHz) setting is recommended for normal patients, and the h3.5 setting provides very high spatial resolution suitable for Micro Flow Imaging (MFI). The MI value (which is normally adjusted using the Acoustic Power dial) is also important for efficiently generating nonlinear signals. An MI value between 0.2 and 0.3 is the recommended setting for Sonazoid imaging, and an MI value around 0.08 is recommended for SonoVue and Definity imaging. However, it must be kept in mind that the MI value is officially an index for evaluating safety. The acoustical pressure that drives the microbubbles may vary due to the differences in the attenuation coefficients of various organs. The Flash-Replenishment Sequence (FRS) is also an efficient technique for microbubble manipulation. Transmission is rapidly changed from low MI to high MI, which causes the microbubbles in the scan volume to burst. When the system returns to low-mi real-time imaging, the inflow of the microbubbles can be observed dynamically. FRS has the advantage of allowing repeated trials during injection, making it easy to readjust the image settings or to change the ultrasound scan planes. MFI is a technique that combines FRS and max-hold processing. The ultrasound system starts max-hold processing immediately after burst-scan following the FRS. In this processing, microvessels in the liver are reconstructed before they are obscured by the inflow into the sinusoids. 3. New techniques and clinical applications: Differential Contrast Harmonic Imaging (Diff-CHI) In Diff-CHI mode, the transmission pulse contains two different frequency components (f 1 and f 2 ). The nonlinear behavior of the microbubbles generates not only the second harmonics (2f 1 and 2f 2 ) of the two frequency components but also a differential frequency component (f 2 -f 1 ). As a result, the reception signals include very wide nonlinear harmonic components, providing images with higher spatial resolution. Motion-correction MFI <feasibility study> In MFI, blur images are sometimes obtained due to changes in the probe position and the patient s respiratory motion. To -69-

5 address this problem, automatic motion correction for MFI has been developed. Our algorithm can calculate the motion vector between frames by placing three small ROIs in the most reliable regions where early inflow of the large vessels is observed. Real-time Volume Imaging with a mechanical 4D probe An abdominal 4D probe (PVT-382MV, 3.75-MHz center frequency) has become available for contrast examinations. Three-dimensional volume imaging with Diff-CHI, 4D MFI, and FRS is expected to be useful for the dynamic observation of the detailed structure of small blood vessels and/or the shapes of tumors. Since this probe is a micro-convex type with a small aperture, it is suitable for performing radiofrequency (RF) ablation as well as for evaluating the therapeutic effects. Intraoperative probes <feasibility study> Intraoperative probes (PLT-705BTH/F) are also now available for contrast examinations. Performing MFI with such high-frequency transducers permits images of fine blood vessels to be reconstructed and extremely small tumors to be detected. This mode is now available in Xario XG, which is a compact system that is suitable for use in the operating room. 4. Conclusion: We plan to continue our research and development into new imaging techniques and clinical applications for microbubble contrast imaging and therapy. Acknowledgements: The authors would like to thank Professor Moriyasu (Tokyo Medical University), Professor Arii (Tokyo Medical and Dental University), and Professor Iijima (Hyogo College of Medicine) for performing the clinical evaluations that provided the images shown in this report. (a) (b) Figure 1. Micro Flow Imaging (a) without motion correction and (b) with motion correction (normal human liver; Sonazoid, 0.5-mL bolus injection). -70-

6 Figure 2. Real-time multiplanar reconstruction (MPR) images and 4D Micro Flow Image (human liver with HCC; Sonazoid, 0.5-mL bolus injection). -71-

7 S6-3 Low Acoustic Power Contrast Harmonic Echo using ALOKA ProSound systems Yasuhiro Ito Aloka Co., Ltd. Medical System Engineering Dept. ALOKA ProSound alpha series has been providing the contrast harmonic function from early stage of research work for its development. The contrast media for diagnostic ultrasound systems were introduced in the market mainly for cardiology research purpose. However, nowadays it becomes much more used for abdominal fields on the clinical scenes. The contrast media for clinical use range from high pressure response medium to low pressure response medium. We have a very good feedback from clinicians about the system performance, especially using low acoustic power pressure contrast medium, named SonoVue which is produced by Bracco International S.A. in Europe (it is not approved by the regulation of Japanese Ministry of Health, Labor and Welfare). On the basis of this experience, we performed quick optimization of the system using the Sonazoid, which is produced by DAIICHI SANKYO Co., Ltd. and realized faithful contrast imaging by Ex-PHD technology of ALOKA for Contrast Echo technology (Sonazoid is approved by the Japanese Ministry of Health, Labor and Welfare). ALOKA's total user support concept includes not only examination but also treatment. The ALOKA ProSound series realized Contrast Harmonic Echo function on the micro convex probe with biopsy which is used for localized treatment such as Radio Frequency Ablation (RFA) therapy. Features of Contrast Harmonic Echo examination using ProSound systems: Provide clear and precise super high quality CHE images with Ex-PHD technologies. It is possible to see and evaluate the contrast medium which is running through hepatic arteries, portal veins and hepatic veins continuously. And also it is possible to evaluate the existence of tumor and the therapeutic effect using the characteristic of Kupffer cell to the foreign material. Dual Dynamic Monitor(DDM) It is a simultaneous display mode of Contrast Harmonic Echo image and Fundamental ultrasound image for comparison. It has a lot of clinically useful functions like Capture Mode, Manual Flash, Color-Map, Contrast analysis function(tic: Time Intensity Curve) and so on. The micro convex probe with biopsy is also available to use Ex-PHD function for Contrast Echo. It is very useful in judgment of therapeutic efficacy, searching the position of biopsy needle and decision for additional treatment. The Contrast Harmonic Echo function is supported not only by high-end system like ProSound alpha 10 but also by the newly-introduced high performance premium compact system ProSound alpha 7. Other ProSound systems also support a part of the function for Contrast Harmonic Echo examination. Now, we have 6 models to support the Contrast Harmonic Echo examination. -72-

8 S6-4 Hybrid Contrast Imaging - Fully Utilized with Raw Data Management - Sei Kato, Masafumi Ogasawara GE Healthcare GE's exclusive TruScan architecture allows raw image data to be stored early in the imaging chain. That means the operator can change the various imaging parameters such as gain, TGC (STC), dynamic range and so on, for the stored image as well as the live scan, and it is a great advantage especially for the contrast exam, which has to be done within the limited time. Because the most imaging parameters can be changed afterwards, the operator at least should be careful about the transmit settings, which cannot be changed afterwards, in advance of the injection. For example, the focal point should be located under the target lesion, and then the acoustic output should be adjusted according to the contrast agent. Once the cine loop is stored as raw data, the operator can manipulate it as if it were the live image. Hybrid Contrast Imaging, introduced on LOGIQ7 breakthrough 2007, is designed to provide the extensive clinical information in conjunction with the raw data management capabilities. The basic concept of Hybrid Contrast Imaging is to acquire and provide the different characteristic images at a time. The system transmits one pulse sequence, consists of multiple firings, along the vector line, and then the received pulses are processed in parallel to get three different image vectors Contrast, Tissue, and Angio. Contrast provides the conventional harmonic contrast image while Tissue provides the B-mode image for the anatomical reference. Angio enhances the flow information of the contrast agent with better suppression of the tissue harmonics and the contrast tissue perfusion. Using the Visualization control on the touch panel, the operator can easily select which image to be displayed on the screen. Of course, all the images are handled as raw data and the Visualization can be changed afterwards. The combination of the different images also provides clinically useful information. For this purpose, Hybrid Contrast Imaging offers two approaches, Hybrid Map and DualView. The color-coded Hybrid Map shows two different images as one image using the different color scheme. Hybrid Contrast is the combination of Contrast and Tissue image - by overlaying the contrast enhancement on the reference B-mode image, it s easy to understand the anatomical features corresponding to the enhanced area. Because Angio mainly shows the fast flow of the contrast agent, Hybrid Angio, the combination of Angio and Contrast, shows the vascularity in different color on the contrast tissue perfusion. DualView is the simultaneous side-by-side display of the reference B-mode image and the contrast image. Thanks to the raw data capabilities, it s quite easy to switch between DualView and the single image display. In conclusion, Hybrid Contrast Imaging provides the extensive clinical information, and its flexibility in conjunction with the raw data management is expected to support the diversified contrast study. -73-

9 S6-5 The System Condition for the Low MI Ultrasound Contrast Agent Noriaki Yoshikawa Philips Electronics Japan, Medical Systems, Marketing Div. Philips iu22 provides the most advanced and comprehensive contrast-enhanced ultrasound solutions for the detection, characterization, treatment and monitoring of the tumors throughout the body. Followings are the features of the Contrast Imaging Technology in Philips systems. (1) 3 modes for contrast imaging Pulse Inversion (PI); Transmit two pulses and the pulse shape is inverted each other, then add the echo from both transmit pulse and extract harmonic factor. This method has the advantage in resolution. Power Modulation (PM); Transmit different amplitude pulses and subtract the echo to cancel the fundamental factor. The advantage of this method is the penetration. PMPI; This method takes advantage of both PI and PM method. (2) Pure wave Crystal Technology Philips Broadband technology utilizes the signals from the entire bandwidth of the transducer. And Pure wave crystal technology achieves the 85% improvement of the efficiency. This technology is adopted on the new transducer C5-1, and this is the first time for convex transducer. This contributes to improve the basic performance for the contrast imaging. (3) MVI It has been known for some time that malignant tumors force the host to grow new blood vessels go supply nutrients to support the rapid growth and spread of the tumor. This process of angiogenesis starts with very small micro vasculature, growing larger feeding vessels over time as the tumor growth. The ability to image angiogenesis is important in cancer diagnosis, as well as therapy assessment research. Micro Vascular Imaging (MVI) tracks the passage of micro bubbles traversing lesional vasculature. This processing measures changes in the image from frame to frame, suppressing any background tissue signal and capturing the bubbles as they pass through the vasculature. (4) Fitting Curve Contrast ultrasound provides opportunities for quantification that may lead to improve diagnosis, therapy monitoring, and patient prognosis. Absolute measurements of volumetric blood flow with contrast ultrasound using indicator dilution techniques is not yet possible due to the requirement of knowing the absolute concentration of the agent. -74-

10 However, measurements of bolus kinetics such as arrival time, time to peak, or time to wash out do hold promise for diagnosing several disease states. Contrast Cineloops can be analyzed to investigate lesion vasculature with QLAB. This software enables visualization and analysis of regions of interests over a Cineloop segment. In QLAB, a gamma-varrate model can be fit to bolus curves providing access to various parameter estimates such as wash-in rates, time to peak, or area under bolus curve. (5)System setting for each imaging Side by side mode is mainly used during the contrast examination. In this mode, Tissue image is displayed on the right side and Contrast image is displayed on the left side. The important system settings are MI and Focus position. MI value should be set not to destroy the bubbles and in usual case, MI would be 0.20 to The focal position affects the uniformity of the acoustic power inside the tissue, and will realize the uniform contrast images. Recommendation is the gain of tissue side should be higher to detect the lesion and Contrast side should be lower to get better contrast images. Usual case, focus position is set to the bottom portion of the region of interest. After injection, Flash image is useful to observe the perfusion of early phase again. System can set the frame number for the high MI flashing. In case of SONAZOID, enough frame number is required to destroy the bubbles in the tissue. During the early phase, gain adjustment is carefully needed In the late phase, before starting the observation, be careful for MI setting not to destroy the bubbles. -75-

11 S6-6 System Setting for Contrast-Enhanced Ultrasound by using Low Mechanical Index Contrast Agents Marketing & Planning Hideo Hirayama Mochida Siemens Medical Systems Co., Ltd. Introduction SIEMENS provides advanced contrast-enhanced ultrasound (CEUS) imaging technology Cadence TM Contrast Pulse Sequencing (CPS) technology for low Mechanical Index (MI) contrast agents. This documentation reads the details of CPS technology and system setting for CEUS by using low MI contrast agents. New Imaging Technique for low MI Contrast Agents Next generation contrast agents such as Sonovue R and Sonazoid R can be good solution to emit nonlinear signal containing harmonics at low MI. The important thing of CEUS in low MI is to detect the contrast signals and to minimize the tissue signals efficiently. Phase modulation method (PM) and amplitude modulation method (AM) are well known as CEUS imaging technologies for low MI. PM transmits 2 pulses that change phase, and gets mainly second harmonics component of nonlinear received signals. AM is changing amplitude, and gets nonlinear fundamental signal. PM is excellent in resolution, and AM is excellent in sensitivity. However, both methods depend on the signal from tissues. To improve this weakness, CPS technology provides better sensitivity and specificity for low MI contrast agents. What is CPS? CPS is multi-pulse imaging method which is integrated solution based on the strong points of PM and AM for better performance. With the improved modulation method, CPS gets both nonlinear fundamental and higher-order harmonics from contrast agents. Therefore, CPS provides better sensitivity and agent-to-tissue specificity than other imaging methods. CPS is especially excellent in the sensitivity of far area, and provides homogeneous opacification even in difficult patients. Furthermore, Capture-mode is added to CPS as a new feature. CPS Capture provides detailed images of macro- and micro-vessel structure. CPS significantly improves diagnostic capability. System Setting In CEUS by using low MI contrast agents, system setting (Table.A) is very important. Most important parameter is MI. The MI setting is various in each low MI contrast agents and each imaging technologies. Generally, the numbers of MI parameter setting for Sonazoid R is slightly bigger than one for Sonovue R to get the same low MI output as Sonovue R. It was also proven by our vitro experiment. In case of CPS, the suitable MI setting for Sonazoid R is about 0.3. However, fine adjustment is necessary for better opacification because imaging performance depends on patient conditions. Focus setting is also important for CEUS. To get homogeneous opacification without decrease of frame rate, SIEMENS SEQUOIA provides dual focus technology which is called Dynamic transmit focus. The second focus point should be placed at most far position for better image quality. Tissue equalization technology (TEQ) is automatic gain control technology for low MI contrast imaging. TEQ is advanced one-button -76-

12 operating features to avoid over gain setting which increases the signal from tissue as well as the signal from contrast agent. For better CPS capture imaging, relatively low CPS gain setting would be recommended. -77-

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