MRI-guided High-intensity Focused Ultrasound Research Articles

Motion Accuracy of Pneumatic Stepper Motor-Driven Robotic System Developed for MRI-Guided High-Intensity Focused Ultrasound Treatment of Prostate Disease

The latest advancement in high-intensity focused ultrasound (HIFU) treatment technology integrates magnetic resonance imaging (MRI) guidance for precise treatment of prostate disease. As conventional electromagnetic motors are not applicable for utilization within MRI scanners, we have developed a prototype robotic system driven by pneumatic stepper motors to control the movement of the HIFU transducer within an intrarectal probe during MRI-guided HIFU treatment procedures. These pneumatic stepper motors were constructed entirely from MRI-compatible plastic materials. Assessment of the robotic system’s MRI compatibility was conducted utilizing a 3.0T MRI scanner, revealing no discernible MRI image distortion with a minor decrease in the signal-to-noise ratio (2.8%) during the motor operation. The robotic system enabled the transducer to move inside the probe with two degrees of freedom, allowing both linear and rotational motion. The positional accuracy of the transducer movement was assessed, yielding ±0.20 and ±0.22 mm accuracies in the forward and backward linear movements, respectively, and ±0.79° and ±0.74° accuracies in the clockwise and counterclockwise rotational motions, respectively. Emulation of authentic HIFU procedures involved creating a two-dimensional array of thermal lesions in a tissue-mimicking phantom, achieving positional accuracy within ±1 mm for the generated HIFU focal spots. The prototype robotic system incorporating pneumatic stepper motors fabricated entirely from MRI-compatible plastic materials has demonstrated the requisite positional accuracy necessary for effective HIFU treatment of prostate disease, indicating substantial promise for future clinical application.

Waste analysis and energy use estimation during MR-HIFU treatment: first steps towards calculating total environmental impact

ObjectivesTo assess the environmental impact of the non-invasive Magnetic Resonance image-guided High-Intensity Focused Ultrasound (MR-HIFU) treatment of uterine fibroids, we aimed to perform a full Life Cycle Assessment (LCA). However, as a full LCA was not feasible at this time, we evaluated the CO2 (carbon dioxide) emission from the MRI scanner, MR-HIFU device, and the medication used, and analyzed solid waste produced during treatment.MethodsOur functional unit was one uterine fibroid MR-HIFU treatment. The moment the patient entered the day care-unit until she left, defined our boundaries of investigation. We retrospectively collected data from 25 treatments to assess the CO2 emission based on the energy used by the MRI scanner and MR-HIFU device and the amount and type of medication administered. Solid waste was prospectively collected from five treatments.ResultsDuring an MR-HIFU treatment, the MRI scanner and MR-HIFU device produced 33.2 ± 8.7 kg of CO2 emission and medication administered 0.13 ± 0.04 kg. A uterine fibroid MR-HIFU treatment produced 1.2 kg (range 1.1–1.4) of solid waste.ConclusionsEnvironmental impact should ideally be analyzed for all (new) medical treatments. By assessing part of the CO2 emission and solid waste produced, we have taken the first steps towards analyzing the total environmental impact of the MR-HIFU treatment of uterine fibroids. These data can contribute to future studies comparing the results of MR-HIFU LCAs with LCAs of other uterine fibroid therapies.Critical relevance statementIn addition to (cost-) effectiveness, the environmental impact of new treatments should be assessed. We took the first steps towards analyzing the total environmental impact of uterine fibroid MR-HIFU.Key points• Life Cycle Assessments (LCAs) should be performed for all (new) medical treatments.• We took the first steps towards analyzing the environmental impact of uterine fibroid MR-HIFU.• Energy used by the MRI scanner and MR-HIFU device corresponded to 33.2 ± 8.7 kg of CO2 emission.Graphical

Minimally Invasive Treatments for Glioblastoma: A Review of Current and Emerging Surgical Technologies

Glioblastoma (GBM) is malignant, primary intracranial neoplasm associated with poor outcomes. Maximal, safe cytoreduction remains an important component of effective treatment for patients with this disease; however, some patients are not candidates for resection due to comorbid status, tumor location, or other factors. In this review, we aimed to describe minimally invasive surgical techniques that are emerging as important tools for improving safety and efficiency in GBM cytoreduction, including for patients with previously unresectable lesions. Specifically, we aimed to describe the commercially available tubular retractor systems and describe the available data regarding the benefits, risks, and utility of these retractors for patients with GBM. Additionally, we aimed to describe laser interstitial thermal therapy (LITT) and its use in GBM, including a description of the mechanism of action, commercially available systems, the steps in surgical implantation, available outcomes data, and future directions for the technology in this context. Finally, we aimed to review the use of MRI-guided high-intensity focused ultrasound (MRgHIFU) in GBM, including a description of its mechanism and data regarding efficacy in GBM. The availability and use of tubular retractors, LITT, and MRgHIFU provide clinically effective alternative methods for cytoreduction in GBM and are also emerging as important tools for the expansion of treatment to GBM that previously may have been classified as nonresectable. This review will assist in the development of an intimate knowledge of the use and utility of these techniques and is important for clinicians caring for patients with GBM.

Gait Function after High-Intensity Focused Ultrasound Thalamotomy for Essential Tremor: Searching for Technique Optimization

Introduction: Essential tremor (ET) is one of the most prevalent movement disorders in adults and may be highly disabling for some. Magnetic resonance image-guided high-intensity focused ultrasound (MRIgFUS) has been shown to control tremor efficaciously and with acceptable risk. To date, paresthesia and ataxia are the most common adverse effects (AE). Nevertheless, the impact of MRIgFUS thalamotomy on balance is not well established. Methods: Thirty-two patients underwent MRIgFUS for ET and completed 6 months of follow-up. Tremor severity and functional disability were assessed using the Essential Tremor Rating Scale and the Quality of Life in Essential Tremor Questionnaire. The Berg Balance Scale (BBS) was applied to objectively measure balance status. Results: All treatments were successful. The sonication target was 1–2 mm above the depth of the intercommissural line. Procedures lasted less the 2 h, with an average of 8 sonications per patient. Twenty-four patients were included in the tremor analysis. The hand tremor score was improved by 76% after 6 months of follow-up and 87% of patients self-reported marked improvement (≥75%). Disability scores showed marked improvement (78%), leading to a significant improvement in quality of life. At the final follow-up, 48% of the patients reported no side effects. When present, AE were generally transient and were considered mild in 96% of affected patients. Paresthesia and subjective feeling of unsteadiness were the most common persistent complaints (23% and 20%, respectively). Regarding objective ataxia, BBS scores remained stable throughout follow-up for most patients. Only 2 patients suffered a mild worsening of balance although no patients experienced moderate or severe ataxia. Conclusions: Subjective feeling of unsteadiness is one of the most frequent AE after MRIgFUS, although objective ataxia is infrequent and mild. Selecting the most appropriate lesion location and procedural parameters should increase treatment benefits while reducing side effects.

Using of MRI-guided focused ultrasound treatment for Parkinson’s disease tremor. Clinical case and literature review

MRI-guided high-intensity focused ultrasound (MRgFUS) is a new emerging and promising procedure applied in a wide range of clinical fi elds in modern medicine. This innovative treatment method follows is an important step towards the ideal surgery of the future: non-invasive, targeted, safe, controlled, eff ective and ambulatory. Randomized studies show high effi cacy in the treatment of tremor for Parkinson disease and essential tremor. Safety is also having similar profi le with other surgical procedures and has a mostly transient character of complications. Such advantages as a non-invasive treatment, controlled eff ect and the safety profi le of the procedure made it popular in the treatment of movement disorders. This article demonstrates a clinical case of the fi rst using of MRgFUS for the treatment of Parkinson’s disease tremor at the Federal Center for Brain Research and Neurotechnologies of the Federal Medical and Biological Agency of Russia in Moscow. The 54-year-old patient with Parkinson disease, 2 Hoehn–Yahr, admitted to our hospital. Severe tremor of right upper extremity impaired his life. Neurosurgical procedure was considered due to medication failed. Patient underwent focused ultrasound thalamotomy with totally tremor relief. No additional neurological impairment was noted, only bradykinesia and rigidity were improved. Patient discharged on 3rd day after the procedure.Conclusions. MRgFUS is an innovative surgical procedure. Advantages of these methods such as non-invasive manner, controlled, safety allowed to be priority procedure for patients with unilateral tremor.

Factors Influencing the Adoption of Magnetic Resonance-Guided High-Intensity Focused Ultrasound for Painful Bone Metastases in Europe, A Group Concept Mapping Study.

Magnetic resonance imaging-guided high-intensity focused ultrasound (MR-HIFU) is an innovative treatment for patients with painful bone metastases. The adoption of MR-HIFU will be influenced by several factors beyond its effectiveness. To identify contextual factors affecting the adoption of MR-HIFU, we conducted a group concept mapping (GCM) study in four European countries. The GCM was conducted in two phases. First, the participants brainstormed statements guided by the focus prompt "One factor that may influence the uptake of MR-HIFU in clinical practice is...". Second, the participants sorted statements into categories and rated the statements according to their importance and changeability. To generate a concept map, multidimensional scaling and cluster analysis were conducted, and average ratings for each (cluster of) factors were calculated. Forty-five participants contributed to phase I and/or II (56% overall participation rate). The resulting concept map comprises 49 factors, organized in 12 clusters: "competitive treatments", "physicians' attitudes", "alignment of resources", "logistics and workflow", "technical disadvantages", "radiotherapy as first-line therapy", "aggregating knowledge and improving awareness", "clinical effectiveness", "patients' preferences", "reimbursement", "cost-effectiveness" and "hospital costs". The factors identified echo those from the literature, but their relevance and interrelationship are case-specific. Besides evidence on clinical effectiveness, contextual factors from 10 other clusters should be addressed to support adoption of MR-HIFU.

Focused Ultrasound and RadioTHERapy for non-invasive palliative pain treatment in patients with bone metastasis: a study protocol for the three armed randomized controlled FURTHER trial

BackgroundCancer-induced bone pain (CIBP), caused by bone metastases, is a common complication of cancer and strongly impairs quality of life (QoL). External beam radiotherapy (EBRT) is the current standard of care for treatment of CIBP. However, approximately 45% of patients have no adequate pain response after EBRT. Magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) may improve pain palliation in this patient population. The main objective of this trial was to compare MR-HIFU, EBRT, and MR-HIFU + EBRT for the palliative treatment of bone metastases.Methods/designThe FURTHER trial is an international multicenter, three-armed randomized controlled trial. A total of 216 patients with painful bone metastases will be randomized in a 1:1:1 ratio to receive EBRT only, MR-HIFU only, or combined treatment with EBRT followed by MR-HIFU. During a follow-up period of 6 months, patients will be contacted at eight time points to retrieve information about their level of pain, QoL, and the occurrence of (serious) adverse events. The primary outcome of the trial is pain response at 14 days after start of treatment. Secondary outcomes include pain response at 14 days after trial enrolment, pain scores (daily until the 21st day and at 4, 6, 12 and 24 weeks), toxicity, adverse events, QoL, and survival. Cost-effectiveness and cost-utility analysis will be conducted.DiscussionThe FURTHER trial aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU—alone or in combination with EBRT—compared to EBRT to relieve CIBP. The trial will be performed in six hospitals in four European countries, all of which are partners in the FURTHER consortium.Trial registrationThe FURTHER trial is registered under the Netherlands Trials Register number NL71303.041.19 and ClinicalTrials.gov registration number NCT04307914. Date of trial registration is 13–01-2020.

Evolving imaging methods of prostate cancer and the emergence of magnetic resonance imaging guided ablation techniques.

Established therapies for prostate cancer (PCa), surgery and radiotherapy, treat the entire gland regardless of the location of the cancerous lesion within the prostate. Although effective, these methods include a significant risk of worsening genitourinary outcomes. Targeted image-guided cancer therapy has gained acceptance through improved PCa detection, localization, and characterization by magnetic resonance imaging (MRI). Minimally-invasive ablative techniques aim to achieve comparable oncological outcomes to radical treatment while preserving genitourinary function. Transurethral ultrasound ablation (TULSA) and next-generation transrectal high-intensity focused ultrasound (HIFU) utilize MRI guidance to thermally ablate prostate tissue under real-time MRI monitoring and active temperature feedback control. Previous trials performed by our group and others, including a large multicenter study in men with localized favorable-risk disease, have demonstrated that TULSA provides effective prostate ablation with a favorable safety profile and low impact on quality of life. Recently, MRI-guided HIFU focal therapy was also shown as a safe and effective treatment of intermediate-risk PCa. Here we review the current literature on ablative techniques in the treatment of localized PCa with a focus on TULSA and HIFU methods.

A new versatile MR-guided high-intensity focused ultrasound (HIFU) device for the treatment of musculoskeletal tumors

Magnetic Resonance (MR) Imaging-guided High Intensity focused Ultrasound (MRgHIFU) is a non-invasive, non-ionizing thermal ablation therapy that is particularly interesting for the palliative or curative treatment of musculoskeletal tumors. We introduce a new modular MRgHIFU device that allows the ultrasound transducer to be positioned precisely and interactively over the body part to be treated. A flexible, MR-compatible supporting structure allows free positioning of the transducer under MRI/optical fusion imaging guidance. The same structure can be rigidified using pneumatic depression, holding the transducer rigidly in place. Targeting accuracy was first evaluated in vitro. The average targeting error of the complete process was found to be equal to 5.4 ± 2.2 mm in terms of focus position, and 4.7° ± 2° in terms of transducer orientation. First-in-man feasibility is demonstrated on a patient suffering from important, uncontrolled pain from a bone metastasis located in the forearm. The 81 × 47 × 34 mm3 lesion was successfully treated using five successive positions of the transducer, under real-time monitoring by MR Thermometry. Significant pain palliation was observed 3 days after the intervention. The system described and characterized in this study is a particularly interesting modular, low-cost MRgHIFU device for musculoskeletal tumor therapy.

P 23 The overlap of lesions placed by MRIgFUS with the cerebellothalamic tract does not adequately explain symptom control in ET

Background: The thalamic ventral intermediate (Vim) nucleus is part of a network that appears to be disrupted in essential tremor (ET) and is the most relevant target of functional neurosurgery to alleviate ET symptoms. As the most important afferent of the VIM, the cerebellothalamic tract (CTT) transmits information from cerebellar nuclei. Disruption of this tract - in the past via subthalatomies and in the present via deep brain stimulation is considered the best option of tremor treatment, partly because of the high anatomical density of CTT fibers before entering the VIM, and partly because of the greater distance to sensory thalamic nuclei. Recently, initial pilot studies have also documented transcranial MRI-guided high-intensity focused ultrasound (MRIgFUS) as an effective treatment modality. Unilateral MRIgFUS lesioning was highly efficacious in reducing contralateral hand tremor in ET with mild and transient adverse effects. However, targeting of MRIgFUS has so far been based on MRI imaging without dedicated evidence of the underlying connectome. Here, we test a method for quantitative analysis of the involved fiber tracts and test whether the measured clinical effect correlates with overlap of the set lesion with individual fiber tracts, such as CTT. Materials and Methods: We revisited pre- and post-procedural MRIs of 6 ET patients (Øage 70,7 (± 8,5) years , Ø Tremor rating (TR) (pre): 43,8 (± 9,8)) who underwent unilateral ablation of the CTT by MRIgFUS. The images, obtained 48 hours (48H) and 3-6 months (3M+) after the procedure, were used to create 3D-models of the lesions which were localized within MNI-space with the pre-procedural MRI and atlas registration using Suretune®. The models were subsequently used to calculate interferences with fiber tracts. A linear model was employed to assess the correlation between the quantitative interference and improvement of the clinical score at two timepoints after the procedure (48H, n=6: TR: 16,7 (±5,5) ; 3M+, n= 5: TR: 19,2 (±7,2)). Results: The lesions volume differed between the 48H (Ø 281.78mm3(±77.77), n=6) and 3M+(Ø 53.82mm3(±22), n=5) conditions (p<0.01). After 48H primarily the CTT (Ø72,4 % (±34)) but also the M1 (Ø36,05 % (±43)) interfered, while after 3M+ the overlap reduced tremendously for the CTT (Ø1% (±1,6), p=0.017) and slightly for the M1(Ø26,7% (±28,4), p=0.67). Preliminary results could not show a correlation between the observed clinical improvement with the interference of the lesions with a specific tract. Discussion: Interestingly, there is no clear correlation between clinical outcome and the overlap between the lesion placed by MRIgFUS and the fibers of the CTT. This might indicate that the observed clinical effect would have to be explained only partially by the targeted CTT but also by other fiber tracts. The data set was too small for a meaningful multivariate regression analysis, but pooling data sets from different centers may mean a solution to this problem in the future.

Lipid Perfluorohexane Nanoemulsion Hybrid for MRI-Guided High-Intensity Focused Ultrasound Therapy of Tumors.

Magnetic resonance imaging-guided high-intensity focused ultrasound (MRI-guided HIFU) is a non-invasive strategy of diagnosis and treatment that is applicable in tumor ablation. Here, we prepared a multifunctional nanotheranostic agent (SSPN) by loading perfluorohexane (PFH) and superparamagnetic iron oxides (SPIOs) in silica lipid for MRI-guided HIFU ablation of tumors. PFH was introduced to improve the ablation effect of HIFU and the ultrasound (US) contrast performance. Due to its liquid-to-gas transition characteristic, it is sensitive to temperature. SPIOs were used as an MRI contrast agent. Silica lipid was selected because it is a more stable carrier material compared with normal lipid. Previous studies have shown that SSPNs have good biocompatibility, stability, imaging, and therapeutic effects. Therefore, this system is expected to develop an important therapeutic agent for MRI-guided HIFU therapy against tumors.

Synthetic CT for the planning of MR-HIFU treatment of bone metastases in pelvic and femoral bones: a feasibility study

ObjectivesVisualization of the bone distribution is an important prerequisite for MRI-guided high-intensity focused ultrasound (MRI-HIFU) treatment planning of bone metastases. In this context, we evaluated MRI-based synthetic CT (sCT) imaging for the visualization of cortical bone.MethodsMR and CT images of nine patients with pelvic and femoral metastases were retrospectively analyzed in this study. The metastatic lesions were osteolytic, osteoblastic or mixed. sCT were generated from pre-treatment or treatment MR images using a UNet-like neural network. sCT was qualitatively and quantitatively compared to CT in the bone (pelvis or femur) containing the metastasis and in a region of interest placed on the metastasis itself, through mean absolute difference (MAD), mean difference (MD), Dice similarity coefficient (DSC), and root mean square surface distance (RMSD).ResultsThe dataset consisted of 3 osteolytic, 4 osteoblastic and 2 mixed metastases. For most patients, the general morphology of the bone was well represented in the sCT images and osteolytic, osteoblastic and mixed lesions could be discriminated. Despite an average timespan between MR and CT acquisitions of 61 days, in bone, the average (± standard deviation) MAD was 116 ± 26 HU, MD − 14 ± 66 HU, DSC 0.85 ± 0.05, and RMSD 2.05 ± 0.48 mm and, in the lesion, MAD was 132 ± 62 HU, MD − 31 ± 106 HU, DSC 0.75 ± 0.2, and RMSD 2.73 ± 2.28 mm.ConclusionsSynthetic CT images adequately depicted the cancellous and cortical bone distribution in the different lesion types, which shows its potential for MRI-HIFU treatment planning.Key Points• Synthetic computed tomography was able to depict bone distribution in metastatic lesions.• Synthetic computed tomography images intrinsically aligned with treatment MR images may have the potential to facilitate MR-HIFU treatment planning of bone metastases, by combining visualization of soft tissues and cancellous and cortical bone.

Lessons learned during implementation of MR-guided High-Intensity Focused Ultrasound treatment of uterine fibroids

BackgroundAlthough promising results have been reported for Magnetic Resonance image-guided High-Intensity Focused Ultrasound (MR-HIFU) treatment of uterine fibroids, this treatment is not yet widely implemented in clinical practice. During the implementation of a new technology, lessons are learned and an institutional learning-curve often has to be completed. The primary aim of our prospective cohort study was to characterize our learning-curve based on our clinical outcomes. Secondary aims included identifying our lessons learned during implementation of MR-HIFU on a technical, patient selection, patient counseling, medical specialists and organizational level.ResultsOur first seventy patients showed significant symptom reduction and improvement of quality of life at 3, 6 and 12 months after MR-HIFU treatment compared to baseline. After the first 25 cases, a clear plateau phase was reached in terms of failed treatments. The median non-perfused volume percentage of these first 25 treatments was 44.6% (range: 0–99.7), compared to a median of 74.7% (range: 0–120.6) for the subsequent treatments.ConclusionsOur findings describe the learning-curve during the implementation of MR-HIFU and include straightforward suggestions to shorten learning-curves for future users. Moreover, the lessons we learned on technique, patient selection, patient counseling, medical specialists and organization, together with the provided supplements, may be of benefit to other institutions aiming to implement MR-HIFU treatment of uterine fibroids.Trial registration ISRCTN14634593. Registered January 12, 2021—Retrospectively registered, https://www.isrctn.com/ISRCTN14634593.

Feasibility of apparent diffusion coefficient in predicting the technical outcome of MR-guided high-intensity focused ultrasound treatment of uterine fibroids – a comparison with the Funaki classification

Purpose To investigate the feasibility of using an apparent diffusion coefficient (ADC) classification in predicting the technical outcome of magnetic resonance imaging-guided high-intensity focused ultrasound (MRgHIFU) treatment of symptomatic uterine fibroids and to compare it to the Funaki classification. Materials and methods Forty-two patients with forty-eight uterine fibroids underwent diffusion-weighted imaging (DWI) before MRgHIFU treatment. The DW images were acquired with five different b-values. Correlations between ADC values and treatment parameters were assessed. Optimal ADC cutoff values were determined to predict technical outcomes, that is, nonperfused volume ratios (NPVr) such that three classification groups were created (NPVr of <30%, 30–80%, or >80%). Results were compared to the Funaki classification using receiver-operating-characteristic (ROC) curve analysis, with statistical significance being tested with the Chi-square test. Results A statistically significant negative correlation (Spearman’s ρ = –0.31, p-value < 0.05) was detected between ADC values and NPV ratios. ROC curve analysis indicated that optimal ADC cutoff values of 980 × 10−6mm2/s (NPVr > 80%) and 1800 × 10−6mm2/s (NPVr < 30%) made it possible to classify fibroids into three groups: ADC I (NPVr > 80%), ADC II (NPVr 30–80%) and ADC III (NPVr < 30%). Analysis of the whole model area under the curve resulted in values of 0.79 for the ADC classification (p-value = 0.0007) and 0.62 for the Funaki classification (p-value = 0.0527). Conclusions Lower ADC values prior to treatment correlate with higher NPV ratios. The ADC classification seems to be able to predict the NPV ratio and may even outperform the Funaki classification. Based on these results DWI and ADC maps should be included in the MRI screening protocol.

The Emerging Role of Magnetic Resonance Imaging-Guided Focused Ultrasound in Functional Neurosurgery.

Functional disorders of the central nervous system (CNS) are diverse in terms of their etiology and symptoms, however, they can be quite debilitating. Many functional neurological disorders can progress to a level where pharmaceuticals and other early lines of treatment can no longer optimally treat the condition, therefore requiring surgical intervention. A variety of stereotactic and functional neurosurgical approaches exist, including deep brain stimulation, implantation, stereotaxic lesions, and radiosurgery, among others. Most techniques are invasive or minimally invasive forms of surgical intervention and require immense precision to effectively modulate CNS circuitry. Focused ultrasound (FUS) is a relatively new, safe, non-invasive neurosurgical approach that has demonstrated efficacy in treating a range of functional neurological diseases. It can function reversibly, through mechanical stimulation causing circuitry changes, or irreversibly, through thermal ablation at low and high frequencies respectively. In preliminary studies, magnetic resonance imaging-guided high-intensity focused ultrasound (MRgHIFU) has been shown to have long-lasting treatment effects in several disease types. The technology has been approved by the FDA and internationally for a number of treatment-resistant neurological disorders and currently clinical trials are underway for several other neurological conditions. In this review, the authors discuss the potential applications and emerging role of MRgHIFU in functional neurosurgery in the coming years.

Volumetric MRI-guided, high-intensity focused ultrasound ablation of uterine leiomyomas: ASEAN preliminary experience.

We sought to present our preliminary experience on the effectiveness and safety of magnetic resonance imaging (MRI)-guided, high-intensity focused ultrasound (HIFU) therapy using a volumetric ablation technique in the treatment of Association of Asian Nations (ASEAN) patients with symptomatic uterine leiomyomas. This study included 33 women who underwent HIFU treatment. Tissue characteristics of leiomyomas were assessed based on T2- and T1-weighted MRI. The immediate nonperfused volume (NPV) ratio and the treatment effectiveness of MRI-guided HIFU on the basis of the degrees of volume reduction and improvement in transformed symptom severity score (SSS) were assessed. The median immediate NPV ratio was 89.8%. Additionally, the median acoustic sonication power and HIFU treatment durations were 150 W and 125 min, respectively. At six-month follow-up, the median leiomyoma volume had decreased from 139 mL at baseline to 84 mL and the median transformed SSS had decreased from 56.2 at baseline to 18.8. No major adverse events were observed. The preliminary results demonstrated that volumetric MRI-guided HIFU therapy for the treatment of symptomatic leiomyomas in ASEAN patients appears to be clinically acceptable with regard to treatment effectiveness and safety.

An MRI-Guided Ring High-Intensity Focused Ultrasound System for Noninvasive Breast Ablation.

High-intensity focused ultrasound (HIFU) has been used for noninvasive treatment of breast tumors, but the present magnetic resonance imaging (MRI)-guided HIFU (MRI-HIFU) systems encounter skin burn. In this study, a novel MRI-HIFU breast ablation system was developed to improve the above problem. The system consisted of the ring HIFU phased-array transducer, a commercial power amplifier, the mechanical positioner, and the graphical user interface control software. MRI thermometry was also established to monitor the temperature in the HIFU-treated tissue. Ablation of pork and the in vivo rabbit leg were carried out to validate the developed system. Results of fat-surrounding pork ablation showed that the ring HIFU system reached a safe margin of 3 mm without fat burn. Moreover, precision of the positioner moving the HIFU focal zone was within 6% error under MRI circumstances. The representative MRI temperature images show that the peak temperatures among the five ablations ranged between 66 °C and 91 °C, and their thermal doses were over 10000. The system could also ablate the biceps femoris of a rabbit without skin burn to form a lesion of 2.5 mm beneath the skin. With the HIFU dose of 315 W/10 s, the MRI temperature map revealed that the maximum temperature and the thermal dose were 60 °C and 3380, respectively. The MRI-guided ring HIFU system can ablate the target tissue near subcutaneous fat without fat burn. The system prototype is a promising tool for clinical implementation.

MR-Guided Focused Ultrasound Central Lateral Thalamotomy for Trigeminal Neuralgia. Single Center Experience.

Background: Trigeminal neuralgia (TN) is a recognized pain condition the treatment of which can be very challenging. Various surgical interventions can be applied in cases of therapy-resistance to drug treatments. The central lateral thalamotomy (CLT) against neurogenic (or neuropathic) pain is based on multiarchitectonic histological as well as physiopathological studies, and integrates the nucleus in a large thalamocortical (TC) and corticocortical network responsible for the sensory, cognitive and affective/emotional components of pain. The advent of the magnetic resonance imaging guided high intensity focused ultrasound (MRgFUS) brought a strong reduction in morbidity and increase in accuracy compared to penetration techniques.Objective: This study was aimed at analyzing the outcome of bilateral MRgFUS CLT for chronic therapy-resistant trigeminal pain, all performed in one single center.Methods: Patients were categorized in Classical, Idiopathic and Secondary TN. By definition, paroxysms lasted for seconds up to 2 min. All patients were screened for trigeminal neurovascular conflict. In case of classical TN, microvascular decompression was proposed. Therapy-resistance and thus indication for MRgFUS CLT was based on the lack of efficacy and/or side effects of antiepileptic and antidepressant drugs. Good outcome was defined by a pain relief ≥50%.Results: Eight patients suffering from chronic therapy-resistant trigeminal neuralgia were treated. All suffered from pain with paroxysmal character. Six patients reported additionally continuous pain. Mean follow-up was 53 months (range: 12–92, median: 60 months). The mean pain relief assessed by patients was 51% (median: 58%, range: 0–90%) at 3 months, 71% (median: 65%, range: 40–100%) at 1 year and 78% (median: 75%, range: 50–100%) at their longest follow-up. This represents 63% good outcomes at 3 months, 88% at 1 year and 100% at last follow-up. Frequency of the mean pain paroxysms decreased from 84 per day preoperative to 3.9 at 1 year postoperatively. There were no serious adverse events in this series.Conclusion: Our study provides preliminary support for the safety and efficacy of MRgFUS CLT, a histologically and pathophysiologically based medial thalamotomy against chronic therapy-resistant trigeminal neuralgia.

Development and clinical evaluation of a 3-step modified manipulation protocol for MRI-guided high-intensity focused ultrasound of uterine fibroids

The clinical applicability of magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) treatment of uterine fibroids is often limited due to inaccessible fibroids or bowel interference. The aim of this study was to implement a newly developed 3-step modified manipulation protocol and to evaluate its influence on the number of eligible women and treatment failure rate. From June 2016 to June 2018, 165 women underwent a screening MRI examination, 67 women of whom were consecutively treated with MR-HIFU at our institution. Group 1 (n = 20) was treated with the BRB manipulation protocol which consisted of sequential applications of urinary bladder filling, rectal filling, and urinary bladder emptying. Group 2 (n = 47) was treated using the 3-step modified manipulation protocol which included (1) the BRB maneuver with adjusted rectal filling by adding psyllium fibers to the solution; (2) Trendelenburg position combined with bowel massage; (3) the manual uterine manipulation (MUM) method for uterine repositioning. A comparison was made between the two manipulation protocols to evaluate differences in safety, the eligibility percentage, and treatment failure rate due to unsuccessful manipulation. After implementing the 3-step modified manipulation protocol, our ineligibility rate due to bowel interference or inaccessible fibroids decreased from 18% (16/88) to 0% (0/77). Our treatment failure rate due to unsuccessful manipulation decreased from 20% (4/20) to 2% (1/47). There were no thermal complications to the bowel or uterus. Implementation of the 3-step modified manipulation protocol during MR-HIFU therapy of uterine fibroids improved the eligibility percentage and reduced the treatment failure rate. Registry number NL56182.075.16 KEY POINTS: • A newly developed 3-step modified manipulation protocol was successfully implemented without the occurrence of thermal complication to the bowel or uterus. • The 3-step modified manipulation protocol increased our eligibility percentage for MR-HIFU treatment of uterine fibroids. • The 3-step modified manipulation protocol reduced our treatment failure rate for MR-HIFU treatment of uterine fibroids.

High-intensity focused ultrasound beam path visualization using ultrasound imaging

In High-Intensity Focused Ultrasound (HIFU) treatment, effective localization of HIFU focus is important for developing a safe treatment plan. While Magnetic Resonance Imaging guided HIFU (MRIgHIFU) can visualize the ultrasound path during the treatment for localizing HIFU focus, it is challenging in ultrasound imaging guided HIFU (USIgHIFU). In the present study, a real-time ultrasound beam visualization technique capable of localizing HIFU focus is presented for USIgHIFU. In the proposed method, a short pulse, with the same center frequency of an imaging ultrasound transducer below the regulated acoustic intensity (i.e., Ispta < 720 mW/cm(2)), was transmitted through a HIFU transducer whereupon backscattered signals were received by the imaging transducer. To visualize the HIFU beam path, the backscattered signals underwent dynamic receive focusing and subsequent echo processing. From in vitro experiments with bovine serum albumin gel phantoms, the HIFU beam path was clearly depicted with low acoustic intensity (i.e., Ispta of 94.8 mW/cm(2)) and the HIFU focus was successfully localized before any damages were produced. This result indicates that the proposed ultrasound beam path visualization method can be used for localizing the HIFU focus in real time while minimizing unwanted tissue damage in USIgHIFU treatment.