In vitro ablation of cardiac valves using high-intensity focused ultrasound

The purpose of this study was to evaluate the possibility of using high-intensity focused ultrasound (US), or HIFU, to create lesions in cardiac valves in vitro. Calf mitral valves and aortic valves were examined. Focused US energy was applied with an operating frequency of 4.67 MHz at a nominal acoustic power of 58 W for 0.2, 0.3 and 0.4 s at 4-s intervals. Mitral valve perforation was achieved with 20.8 +/- 3.7 exposures of 0.2 s, 15.4 +/- 2.1 exposures of 0.3 s or 11.2 +/- 2.3 exposures of 0.4 s. Aortic valve perforation was achieved with 13.3 +/- 2.4 exposures of 0.2 s, 10.3 +/- 2.2 exposures of 0.3 s or 8.4 +/- 1.8 exposures of 0.4 s. The mean diameter of the perforated area was 1.09 +/- 0.11 mm. The lesions were slightly discolored and coagulation of tissue around the perforation was observed. HIFU was successful in perforating cardiac valves. With further refinement, HIFU may prove useful for valvulotomy or valvuloplasty.     

Non-invasive High-Intensity Focused Ultrasound Treatment of Liver Tissues in an In Vivo Porcine Model: Fast,Large and Safe Ablations Using a Toroidal Transducer

A toroidal high-intensity focused ultrasound (HIFU) transducer was used to non-invasively treat liver tissues in vivo in a pig model. The transducer was divided into 32 concentric rings with equal surface areas operating at 2.5 MHz. First, attenuation of skin, fat, muscle and liver tissues was measured in fresh animal samples to adjust the energy delivered to the focal zone. Then, 8 animals were included in the present protocol and placed in a dorsal decubitus proclive position at an angle of 15°. The device was held by hand, and sonications were performed during apnea. Two thermal HIFU lesions were created in 40 s in each animal. The average abdominal wall thickness was 14.8 ± 1.3 mm (12.5–17.6 mm). The longest and shortest axes of the HIFU ablations were 20.9 ± 6.3 mm (14.0–33.7 mm) and 14.2 ± 5.5 mm (7.0–22.0 mm), respectively. All HIFU lesions were visible on sonograms. The correlation between the dimensions of the HIFU lesions observed on sonograms and those obtained during gross examination was r = 0.84. Creating large and fast ablations with reliable ultrasound imaging guidance in the liver using this handheld device may represent a new therapeutic option for patients with liver tumors.     

In vitro and in vivo ablation of porcine renal tissues using high-intensity focused ultrasound

The aim of this paper is to present issues regarding the thermal ablation of porcine renal tissues in vitro and in vivo using high-intensity focused ultrasound (HIFU). Production of lesions in the cortex in vitro is consistent, whereas lesions in the medulla are created whenever there are no air spaces in the medulla. Typically, the lesion length at 2000 W/cm2 and 5-s pulse duration is around 20 mm and the corresponding width around 3 mm. Lesioning of a large volume was achieved by moving the transducer in a grid formation. Lesioning through a fat layer is possible provided that there are no air spaces between the fat and kidney interface. It was found that, above 3200 W/cm2 with 5-s pulse duration at 4 MHz, cavitation activity occurred in most of the lesions created.     

Fast and Selective Ablation of Liver Tumors by High-Intensity Focused Ultrasound Using a Toroidal Transducer Guided by Ultrasound Imaging: The Results of Animal Experiments

This study demonstrated that high-intensity focused ultrasound (HIFU) produced with an intra-operative toroidal-shaped transducer causes fast, selective liver tumor ablations in an animal model. The HIFU device is composed of 256 emitters working at 3 MHz. A 7.5 MHz ultrasound imaging probe centered on the HIFU transducer guided treatment. VX2 tumor segments (25 mg) were implanted into the right lateral liver lobes of 45 New Zealand rabbits. The animals were evenly divided into groups 1 (toroidal HIFU ablation), 2 (surgical resection) and 3 (untreated control). Therapeutic responses were evaluated with gross pathology and histology 11 d post-treatment. Toroidal transducer-produced HIFU ablation (average ablation rate 10.5 cc/min) allowed fast and homogeneous tumor treatment. Sonograms showed all ablations. VX2 tumors were completely coagulated and surrounded by safety margins without surrounding-organ secondary HIFU lesions. HIFU group tumor volumes at autopsy (39 mm³) were significantly lower than control group volumes (2610 mm³, p < 0.0001). HIFU group tumor metastasis (27%) was lower than resected (33%) and control (67%) group metastasis. Ultrasound imaging, gross pathology and histology results supported these outcomes. HIFU procedures had no complications. Rabbit liver tumor ablation using a toroidal HIFU transducer under ultrasound imaging guidance might therefore be an effective intra-operative treatment for localized liver metastases.     

Image-guided acoustic hemostasis for hemorrhage in the posterior liver

We investigated the use of ultrasound image-guided high intensity focused ultrasound (HIFU) to stop bleeding from injuries in the posterior liver. A HIFU transducer with focal length of 3.5 cm and frequency of 3.2 MHz was integrated with an intraoperative high-resolution ultrasound-imaging probe. Wedge tissue extractions, 30-mm long, 5-mm wide and 8-mm deep, were made in the posterior liver surface of five pigs to induce bleeding. The device was positioned on the anterior surface of the liver and HIFU was applied using ultrasound image-guidance. Hemostasis was achieved in 66 +/- 18 s (mean +/- standard deviation) for 17 HIFU treatments. During 7 min of sham HIFU treatment, none of the control incisions (n = 7) became hemostatic. Ultrasound image-guided HIFU offers a promising method for hemostasis in surgical settings in which the hemorrhage site is hidden and/or not accessible.     

Use of overpressure to assess the role of bubbles in focused ultrasound lesion shape in vitro

Overpressure--elevated hydrostatic pressure--was used to assess the role of gas or vapor bubbles in distorting the shape and position of a high-intensity focused ultrasound (HIFU) lesion in tissue. The shift from a cigar-shaped lesion to a tadpole-shaped lesion can mean that the wrong area is treated. Overpressure minimizes bubbles and bubble activity by dissolving gas bubbles, restricting bubble oscillation and raising the boiling temperature. Therefore, comparison with and without overpressure is a tool to assess the role of bubbles. Dissolution rates, bubble dynamics and boiling temperatures were determined as functions of pressure. Experiments were made first in a low-overpressure chamber (0.7 MPa maximum) that permitted imaging by B-mode ultrasound (US). Pieces of excised beef liver (8 cm thick) were treated in the chamber with 3.5 MHz for 1 to 7 s (50% duty cycle). In situ intensities (I(SP)) were 600 to 3000 W/cm(2). B-mode US imaging detected a hyperechoic region at the HIFU treatment site. The dissipation of this hyperechoic region following HIFU cessation corresponded well with calculated bubble dissolution rates; thus, suggesting that bubbles were present. Lesion shape was then tested in a high-pressure chamber. Intensities were 1300 and 1750 W/cm(2) ( +/- 20%) at 1 MHz for 30 s. Hydrostatic pressures were 0.1 or 5.6 MPa. At 1300 W/cm(2), lesions were cigar-shaped, and no difference was observed between lesions formed with or without overpressure. At 1750 W/cm(2), lesions formed with no overpressure were tadpole-shaped, but lesions formed with high overpressure (5.6 MPa) remained cigar-shaped. Data support the hypothesis that bubbles contribute to the lesion distortion.     

Effects of fascia lata on HIFU lesioning in vitro

The effects of fascia lata on high intensity focused ultrasound (US), or HIFU,-induced lesions were demonstrated through comparison with and without fascia lata in bovine thigh muscle tissue. Experiments were conducted in an arrangement with a three-way multiscan ultrasonic inspection system and imaging done by B-mode US. Bovine thigh muscle (8-cm thick) was treated with 1.5 MHz for 8 s. Spatial peak intensity (ISP) was 3000 W/cm2. B-mode US imaging detected appearance at the HIFU treatment site. At a free-field intensity of 4000 W/cm2, the observed lesion length (along the axis) with fascia lata was 12 +/- 1.82 mm, compared with 4 +/- 1.54 mm for samples without fascia lata. At 3000 W/cm2, the values for samples with fascia lata and samples without fascia lata, respectively, were 13 +/- 1.50 mm and 2 +/- 1.42 mm. During a 30-s exposure, at ISP of 2000 W/cm2, the peak temperature reached 41 degrees C in samples without fascia lata and 70 degrees C in samples with fascia lata. At ISP of 3000 and 4000 W/cm2, the peak temperature reached, respectively, 73 degrees C and 84 degrees C in samples without fascia lata, compared with 102 degrees C and 104 degrees C, respectively, for samples with fascia lata. The results confirm that fascia lata contributes to increasing tissue necrosis, temperature elevation and echogenicity in US images.     

In vitro mitral chordal cutting by high intensity focused ultrasound

Mitral regurgitation, when it arises from functional restriction of mitral leaflet closure, can be relieved by surgical cutting of the mitral tendineae chordae. We hypothesized that high intensity focused ultrasound (HIFU) might be useful as a noninvasive extracorporeal technique for cutting mitral chordae. As a pilot study to test this hypothesis, we examined the in vitro feasibility of using HIFU to cut calf mitral chordae with diameters from 0.2 to 1.6 mm. Sixty-seven percent of chordae were completely cut with HIFU, operated at 4.67 MHz and 45 W acoustic power, with up to 120 pulses of 0.3-s duration at 2-s intervals. Forty-five percent were completely cut when the pulse duration was reduced to 0.2 s. The average diameter of those chordae, which were completely cut, was significantly smaller than that of incompletely cut chordae (0.59 +/- 0.30 versus 1.14 +/- 0.30 mm with a pulse duration of 0.2 s, p < 0.0001; 0.68 +/- 0.29 versus 1.32 +/- 0.20 mm with a pulse duration of 0.3 s, p < 0.0001). For each pulse duration, the number of pulses required for complete cutting exhibited a strong positive correlation with the chordae diameter. In conclusion, in vitro feasibility of mitral chordal cutting by HIFU depended on the diameter of chordae but was controllable by HIFU settings. (E-mail: abeyukio@aol.com).     

High-frequency ultrasound m-mode imaging for identifying lesion and bubble activity during high-intensity focused ultrasound ablation

Effective real-time monitoring of high-intensity focused ultrasound (HIFU) ablation is important for application of HIFU technology in interventional electrophysiology. This study investigated rapid, high-frequency M-mode ultrasound imaging for monitoring spatiotemporal changes during HIFU application. HIFU (4.33 MHz, 1 kHz PRF, 50% duty cycle, 1 s, 2600?6100 W/cm²) was applied to ex vivo porcine cardiac tissue specimens with a confocally and perpendicularly aligned high-frequency imaging system (Visualsonics Vevo 770, 55 MHz center frequency). Radio-frequency (RF) data from M-mode imaging (1 kHz PRF, 2 s × 7 mm) was acquired before, during and after HIFU treatment (n = 12). Among several strategies, the temporal maximum integrated backscatter with a threshold of +12 dB change showed the best results for identifying final lesion width (receiver-operating characteristic curve area 0.91 ± 0.04, accuracy 85 ± 8%, compared with macroscopic images of lesions). A criterion based on a line-to-line decorrelation coefficient is proposed for identification of transient gas bodies.     

高强度聚焦超声定位损伤离体人子宫肌瘤的研究

目的探讨高强度聚焦超声(HIFU)体外治疗子宫肌瘤的安全性、有效性及临床可行性。方法用频率0.8MHz,焦距117mm,声强5762.7W/cm2的HIFU对17例离体人子宫肌瘤进行扫描切除,并将治疗过程中声像图表现与TTC染色及组织学切片进行对比观察。结果17例子宫肌瘤在治疗后B超下均出现了强回声团,TTC染色不着色,光镜下细胞核固缩,声像图与TTC染色及组织学结果吻合,强回声区面积与凝固性坏死区面积呈显著正相关(γ＝0.878,P＜0.01)。结论HIFU能够准确安全切除子宫肌瘤,治疗前后超声图像变化是无创监测HIFU切除肌瘤的有用手段。     

Application of high-intensity focused ultrasound for umbilical artery occlusion in a rabbit model.

OBJECTIVES: To investigate the application of high-intensity focused ultrasound (HIFU) for fetal umbilical artery blood flow occlusion in a rabbit model. METHODS: A prototype HIFU transducer in combination with an imaging probe with Doppler capability was constructed. Using this transducer, HIFU was applied at 1.4, 2.75 or 5.5 kW/cm(2) through the maternal abdominal skin to the fetal intra-abdominal umbilical arteries of four time-mated Japanese White rabbits (11 fetuses) on gestational day 25. Courses of 5-s HIFU exposure were performed until cessation of umbilical blood flow and cardiac arrest were confirmed by Doppler ultrasonography. Fetal necropsy was performed and exposed lesions were assessed by microscopic histological analysis. RESULTS: The mean diameter of the fetal umbilical artery was 0.6 +/- 0.2 mm and the mean peak systolic velocity of arterial blood flow was 44.7 +/- 18.5 cm/s. When HIFU was applied at 5.5 kW/cm(2), blood flow was completely occluded within 15 courses. HIFU exposure brought about vacuolar degeneration and destruction of elastic fibers in the tunica media of the artery. CONCLUSIONS: HIFU can be used to occlude umbilical artery blood flow in fetal rabbits.     

Voltage sensitivity response of ultrasonic hydrophones in the frequency range 0.25-2.5 MHz

Frequency responses of different PVDF polymer hydrophones, including membrane and needle designs, were measured and are presented in terms of end-of-cable voltage sensitivity vs. frequency over a wide, 4.5-octave bandwidth ranging from 0.25-2.5 MHz. The experimental data indicate that the membrane PVDF hydrophones can exhibit uniform, to within +/- 0.75 dB, responses. However, a widely used bilaminar membrane hydrophone-preamplifier combination may display sensitivity variations of +/- 2 dB. Also, even well-designed needle-type hydrophones show a more distinct sensitivity variation below 1 MHz that is on the order of 3-4 dB. The overall uncertainty of the calibration technique was estimated to be better than +/- 2 dB in the frequency range considered. The technique, which uses a combination of swept frequency chirp and reciprocity so that both the relative and absolute plots of sensitivity vs. frequency can be obtained, is also briefly described. The results of this work are important to implement procedures for adequate determination of the mechanical index of ultrasound (US) imaging devices. Mechanical index is widely accepted as a predictor of potential bioeffects associated with cavitation phenomena. Also, absolute calibration data are essential in development of therapeutic procedures based on the use of high-intensity focused ultrasound (HIFU), and in characterization of conventional therapeutic US applicators operating at frequencies below 1 MHz.     

Effects of ultrasonic exposure parameters on myocardial lesions induced by high-intensity focused ultrasound.

OBJECTIVE: This study evaluated variables relevant to creating myocardial lesions using high-intensity focused ultrasound (HIFU). Without an effective means of tracking heart motion, lesion formation in the moving ventricle can be accomplished by intermittent delivery of HIFU energy synchronized by electrocardiographic triggering. In anticipation of future clinical applications, multiple lesions were created by brief HIFU pulses in calf myocardial tissue ex vivo. METHODS: Experiments used f-number 1.1 spherical cap HIFU transducers operating near 5 MHz with in situ spatial average intensities of 13 and 7.4 kW/cm2 at corresponding depths of 10 and 25 mm in the tissue. The distance from the HIFU transducer to the tissue surface was measured with a 7.5-MHz A-mode transducer coaxial and confocal with the HIFU transducer. After exposures, fresh, unstained tissue was dissected to measure visible lesion length and width. Lesion dimensions were plotted as functions of pulse parameters, cardiac structure, tissue temperature, and focal depth. RESULTS: Lesion size in ex vivo tissue depended strongly on the total exposure time but did not depend strongly on pulse duration. Lesion width depended strongly on the pulse-to-pulse interval, and lesion width and length depended strongly on the initial tissue temperature. CONCLUSIONS: High-intensity focused ultrasound creates well-demarcated lesions in ex vivo cardiac muscle without damaging intervening or distal tissue. These initial studies suggest that HIFU offers an effective, noninvasive method for ablating myocardial tissues to treat several important cardiac diseases.     

高强度聚焦超声辐照离体及在体心肌组织的比较研究

目的　探讨并比较高强度聚焦超声(HIFU)定位损伤离体心肌及活体心肌的量效关系。方法　采用不同功率(3W ,4W ,5W)的HIFU ,在不同辐照时间(5S ,8S ,10S ,15S ,2 0S ,60S ,180S)的作用下,对5只正常猪离体心脏及8只活体兔心脏进行定位损伤,观察并测定损伤区形态及体积,并对损伤区进行病理学检查。结果　不同剂量下HIFU所致的生物学焦域范围为1～3 0 0mm3 ,不同处理因素间损伤体积具有显著性差异(P <0 .0 5 ) ,相同剂量下离体心肌受损体积大于在体心肌的受损体积。损伤形态随剂量增大由椭球形向锥体形、不规则形发展。组织学观察可见凝固性坏死及损伤区与正常心肌组织的明显分界。结论　HIFU可定点使离体心肌及活体心肌发生坏死而不伤及周围组织。     

Pulsatile flow phantom for ultrasound image-guided HIFU treatment of vascular injuries

A pulsatile flow phantom was developed for studies of ultrasound image-guided high intensity focused ultrasound (HIFU) application in transcutaneous hemostasis of injured blood vessels. The flow phantom consisted of a pulsatile pump system with instrumented excised porcine carotid artery, which was imbedded in a transparent agarose gel to model structural configuration of in vivo tissues. Heparinized porcine blood was circulated through the phantom. The artery was injured using an 18-gauge needle to model a penetrating injury in human peripheral vasculature. A HIFU transducer with the diameter of 7 cm, focal length of 6.3 cm and frequency of 3.4 MHz was used to seal the puncture. Ultrasound imaging was used to localize and target the puncture site and to monitor the HIFU treatment. Triphasic blood flows present in the human arteries were reproduced, with flow rates of 50 to 500 mL/min, pulse rates of 62 to 138 beats/min and peak pressures of 100 to 250 mm Hg. The penetrating injury of an artery was mimicked successfully in the flow phantom setting and was easily visualized both optically through the transparent gel and with power Doppler ultrasound imaging. Hemostasis was achieved in 55 +/- 31 s (n = 9) of HIFU application. Histologic observations showed that a HIFU-sealed puncture was filled with clotted blood and covered with a fibrin cap. The pulsatile flow phantom provides a controlled and repeatable environment for studies of transcutaneous image-guided HIFU application in hemostasis of a variety of blood vessel injuries.     

In vitro strain measurement in the porcine antrum using ultrasound doppler strain rate imaging

Strain rate imaging (SRI) enables study of deformation in soft tissues. The aim of this study was to evaluate the accuracy of SRI in measuring strain in the porcine antral wall in vitro. An experimental set-up enabled controlled distension of a porcine stomach in a saline reservoir. Radial strain obtained by SRI was compared with radial strain calculated from B-mode ultrasonography. Circumferential strain obtained by SRI was compared with circumferential strain calculated from sonomicrometry. The agreement between radial strain values measured by SRI and B-mode, along and across several ultrasound (US) beams, using US frequency 6.7 MHz and strain length (SL) = 1.9 mm was = -1.0 +/- 12.1% and 0.5 +/- 13.4%, respectively (mean difference +/- 2SD%) and it was better than with SL 1.2 mm. Compared with sonomicrometry, SRI-determined circumferential strain using 6.7 MHz and SL = 1.9 mm was less accurate, whether averaging along or across several US beams (-9.2 +/- 46.7% and 13.8 +/- 51.2%, respectively). In conclusion, SRI gave accurate measurement of radial strain of the antral wall, but seemed to be less accurate for measurement of circumferential strain for this in vitro set-up.     

高强度聚焦超声致香猪外阴损伤的研究

目的 观察高强度聚焦超声（ＨＩＦＵ）对香猪外阴的损伤作用及愈合过程。旨在为外阴营养不良探索新的治疗方法。方法 对５只小型香猪的外阴进行ＨＩＦＵ（频率９．８４ＭＨｚ,声强１１０９Ｗ／ｃｍ＾２）连续扫描定位损伤,ＨＩＦＵ辐照后即刻、３ｄ、７ｄ、１４ｄ、２１ｄ、３０ｄ行彩超、病理检查、动态监测其损伤变化情况。结果 ＨＩＦＵ可准确定位损伤靶区组织。其相临表面皮肤组织不受损伤。ＨＩＦＵ后靶区超声影像学变化与     

New integrated imaging high intensity focused ultrasound probe for transrectal prostate cancer treatment

The present study proposes a new integrated imaging (II) high-intensity focused ultrasound (HIFU) probe intended as an improvement to the Ablatherm prostate cancer treatment. Because of a perforation in the center of the II probe, the expected lesion differs from the one obtained for the original Ablatherm probe. In this paper, the new geometry and the strategy followed to establish the treatment parameters are presented. The original probe has a 40-mm focal length, a 50-mm aperture and is truncated at 31 mm. The II probe has a 45-mm focal length, a 61-mm aperture, a central perforation of 25 mm and is truncated at 31 mm. Both probes operate at 3 MHz. A mathematical model for lesion prediction was used for setting the treatment parameters for the II probe. These parameters should ensure equivalence between the lesions obtained with the original and II probes. Simulation-obtained parameters were validated by in-vitro and in-vivo (on liver of 70 New Zealand rabbits) experiments. The new II probe was used clinically to treat 30 patients. The mean age was 70.9 +/- 5.3 years (SD), the mean prostate volume 26.9 +/- 7.7 mL and the mean serum prostate specific antigen (PSA) concentration before treatment was 9.2 +/- 5.5 ng/mL. Simulations showed that for the II probe acoustical power and duration when the transducer is inactive should be reduced of 14% and 1s. In-vitro and in-vivo experiments confirmed the equivalence between the lesions obtained with the two probes. The lesion volume obtained under in-vitro conditions (for a traversed tissue depth of 16 mm to the focus) was 5 +/- 0.4 cm(3) and 5.1 +/- 0.5 cm(3) for the original and II probes, respectively. Under in-vivo conditions, the lesion volume (for a traversed tissue depth of 18 mm) was 5.3 +/- 1.1 cm(3) and 5.1 +/- 1.1 cm(3) for the original and II probes, respectively. During the clinical trial, a correction of + 1s in the exposure time was required to recreate the same degree of efficacy observed with the original probe (p = 0.97): 66.7 % of negative biopsies and 75% of patients with PSA at 3 mo < or =1 ng/mL. The morbidity observed was minimal and identical to that observed with the original probe.     

A new ultrasonic probe for endosonographic imaging of the upper GI-tract. Preliminary observations

A new ultrasonic probe (7.5 MHz, diameter 3.7 mm) was used in vitro in 3 gastric resection specimens and in vivo in 12 patients in an attempt to visualize normal and pathological wall structure of the esophagus, stomach and duodenum via the working channel of a gastroscope, and of the biliary tract via the percutaneous approach. In 5 of these patients conventional endosonography was performed. The probe visualizes the normal layer structure and pathological lesions of the upper GI-tract wall, since it can be accurately positioned at the structure of interest under visual control; water is instilled into the hollow organs to improve transmission of the ultrasound beam. Intra- and transmural changes such as blood vessels in the wall of the esophagus and stomach in portal hypertension, or gastric and esophageal tumors were demonstrated. The important advantage of the probe is that it can be used in stenosed or narrowed hollow organs, where conventional endosonography fails. However, the depth of penetration of the ultrasonic beam (10-15 mm) and circumferential imaging of the gastric wall are still inferior to those of conventional endoscopic ultrasound. As the focus distance of the ultrasound probe to the biliary ducts is too small, visualization of the biliary system is incomplete. Technical improvements could make this new probe an irreplacable diagnostic tool in the future.     

Combination of HIFU therapy with contrast-enhanced sonography for quantitative assessment of therapeutic efficiency on tumor grafted mice

The objective was to evaluate treatment efficiency of a new high-intensity focused ultrasound (HIFU) prototype combining a therapeutic transducer with a sonographic probe. The optimal HIFU sequence was defined on ex vivo samples before in vivo evaluation of tumor ablation was performed by perfusion quantification after contrast agent injection. The original feature of this prototype is a 9-MHz sonographic probe in a HIFU device and connected to an Aplio (Toshiba) sonograph. Acoustical power and treatment time were determined on ex vivo livers to generate 1-cm-long lesions. Lesion reproducibility was assessed for the power and treatment time selected. The gap between lesions and HIFU displacement shot procedures were optimized to ablate a 1-cm3 volume. The optimized protocol was applied to five murine tumors in vivo. Tumor ablation was quantified according to (1) contrast uptake (CU) after HIFU using perfusion software (Toshiba) in "vascular recognition imaging" mode and Sonovue (Bracco) contrast agent, and (2) the percentage of necrosis quantified on histologic slides. Ex vivo results: optimized settings, at 442 W/cm2 applied during three cycles (3 s on/5 s off) generated 10 identical elementary lesions measuring 9.78 (+/-0.66) * 2.11 (+/-0.33) mm2. A 4-mm gap between adjacent lesions and a 2-min pause between shot lines were found optimal. In vivo results: 60 % (+/-22) mean reduction in CU after HIFU and tumor necrosis histologically estimated at 58 % (+/-5.7) were quantified for the five animals. The therapeutic potential of this HIFU prototype was demonstrated in vivo through objective quantification of tumor ablation based on CU.