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In a randomized, sham-controlled trial involving 40 patients, therapeutic lesions on one side in the subthalamic nucleus were produced by focused ultrasound. At 4 months, motor performance was better in the active-treatment group. Twelve patients had neurologic deficits, many of which resolved by 12 months.

Objectives To assess the feasibility, safety and preliminary efficacy of magnetic resonance-guided focused ultrasound (MRgFUS) for the treatment of extra-abdominal desmoid tumours. Methods Fifteen patients with desmoid fibromatosis (six males, nine females; age range, 7–66 years) were treated with MRgFUS, with seven patients requiring multiple treatments (25 total treatments). Changes in viable and total tumour volumes were measured after treatment. Efficacy was evaluated using an exact one-sided Wilcoxon test to determine if the median reduction in viable tumour measured immediately after initial treatment exceeded a threshold of 50 % of the targeted volume. Median decrease after treatment of at least two points in numerical rating scale (NRS) worst and average pain scores was tested with an exact one-sided Wilcoxon test. Adverse events were recorded. Results After initial MRgFUS treatment, median viable targeted tumour volume decreased 63 %, significantly beyond our efficacy threshold ( P  = 0.0013). Median viable total tumour volume decreased (105 mL [interquartile range {IQR}, 217 mL] to 54 mL [IQR, 92 mL]) and pain improved (worst scores, 7.5 ± 1.9 vs 2.7 ± 2.6, P  = 0.027; average scores, 6 ± 2.3 vs 1.3 ± 2, P  = 0.021). Skin burn was the most common complication. Conclusions MRgFUS significantly and durably reduced viable tumour volume and pain in this series of 15 patients with extra-abdominal desmoid fibromatosis. Key Points • Retrospective four-centre study shows MRgFUS safely and effectively treats extra-abdominal desmoid tumours • This non-invasive procedure can eradicate viable tumour in some cases • Alternatively, MRgFUS can provide durable control of tumour growth through repeated treatments • Compared to surgery or radiation, MRgFUS has relatively mild side effects

Abstract BACKGROUND Several feasibility studies and a randomized, controlled, multicenter trial have demonstrated the safety and efficacy of unilateral transcranial magnetic resonance-guided focused ultrasound (FUS) lesioning of the ventral intermediate thalamic nucleus in treating essential tremor. OBJECTIVE To evaluate the safety and efficacy of FUS thalamotomy in a Japanese patient cohort through a prospective, multicenter, single-arm confirmatory trial. METHODS A total of 35 patients with disabling refractory essential tremor underwent unilateral FUS thalamotomy and were followed up for 12 post-treatment months. Safety was measured as the incidence and severity of treatment-related adverse events. Efficacy was measured as the tremor severity and quality of life improvements using the Clinical Rating Scale for Tremor and Questionnaire for Essential Tremor. RESULTS The mean skull density ratio (SDR) was 0.47. There was a significant decrease in the mean postural tremor score of the treated hand from baseline to 12 mo by 56.4% (95% CI: 46.7%-66.1%; P < .001), which was maintained at last follow-up. Quality of life improved by 46.3% (mean overall Questionnaire for Essential Tremor score of 17.4 [95% CI: 12.1-22.7]) and there were no severe adverse events. The most frequent adverse event was gait disturbance and all events resolved. CONCLUSION Unilateral FUS thalamotomy allowed significant and sustained tremor relief and improved the quality of life with an outstanding safety profile. The observed safety and efficacy of FUS thalamotomy were comparable to those reported in a previous multicenter study with a low SDR, and inclusion of the low SDR group did not affect effectiveness. Graphical Abstract Graphical Abstract

Objectives To compare outcomes in pain relief and motor functional recovery in patients with an osteoid osteoma treated by magnetic resonance guided focused ultrasound surgery (MRgFUS) or radiofrequency ablation (RFA) using a propensity score matching study design. Methods Thirty patients with osteoid osteomas were included in this institutional review board (IRB)-approved study. MRgFUS was performed in 15 subjects. These subjects were matched by propensity analysis with a group of 15 subjects treated by RFA. Pain relief in terms of complete response (CR) and motor functional recovery were measured. Results A similar proportion of subjects treated by MRgFUS (94 %) or RFA (100 %) experienced CR 12 weeks after treatment, with no significant difference. The improvement in pain control following MRgFUS or RFA paralleled with improved motor functional recovery. The treatment failure rate was 6.6 % in the MRgFUS group and 0 % in the RFA group. No major complications were observed following either ablative treatment. Conclusions Although this study involved a limited number of patients, MRgFUS favourably improves perceived pain and motor functional recovery, with no major complications. No difference was found in the achievement of primary and secondary outcome measures with respect to RFA. Key Points • To demonstrate the effectiveness of a recent technique for treating osteoid osteoma • MRgFUS results compared with results of the gold standard treatment (RFA) • MRgFUS is effective both from a clinical and functional point of view • No significant side effects compared with RFA

Background The incidence of caesarean scar pregnancy (CSP) has significantly increased due to the increasing prevalence of caesarean deliveries and advances in diagnostic imaging. However, no consensus has yet been reached on the optimal therapeutic approach. Type II CSP leads to disease heterogeneity, characterized by multiple treatment options and the absence of a unified therapeutic approach. Hysteroscopic treatment for CSP has demonstrated a notable success rate, particularly in cases of type I CSP. High-intensity focused ultrasound (HIFU) ablation has emerged as a novel, non-invasive treatment option that minimizes intraoperative blood loss. However, its use may be excessive in low-risk cases. Here, we report a protocol for a randomized clinical trial designed to evaluate the necessity of performing HIFU in CSP treatment when combined with suction curettage under hysteroscopic guidance. Methods We aim to propose a randomized clinical trial that will enroll 140 participants. All participants will undergo surgical suction curettage guided by hysteroscopy, randomized into groups with or without HIFU pretreatment. Data on demographic characteristics, disease characteristics, ultrasound findings, and laboratory test results will be collected before the intervention. The primary outcome will be the intraoperative blood loss. Secondary outcomes will include the incidence of near haemorrhage, therapeutic success rates, and subsequent pregnancy outcomes within a 2-year follow-up period. Discussion Hysteroscopy has exhibited favourable therapeutic outcomes in the management of CSP, though it remains associated with a risk of intraoperative haemorrhage. HIFU has shown promise as a preoperative adjuvant modality. However, the comparative clinical advantages of standalone hysteroscopic intervention versus HIFU-assisted protocols are insufficiently explored in prospective clinical studies. This investigation seeks to assess both the standalone efficacy of hysteroscopic resection and the efficacy of combined therapy incorporating HIFU pretreatment for type II CSP. Trial registration Registration number: ChiCTR2000034332. Registration date: 2nd July 2020.

PurposeTo quantitatively assess 12-month prostate volume (PV) reduction based on T2-weighted MRI and immediate post-treatment contrast-enhanced MRI non-perfused volume (NPV), and to compare measurements with predictions of acute and delayed ablation volumes based on MR-thermometry (MR-t), in a central radiology review of the Phase I clinical trial of MRI-guided transurethral ultrasound ablation (TULSA) in patients with localized prostate cancer.Materials and methodsTreatment day MRI and 12-month follow-up MRI and biopsy were available for central radiology review in 29 of 30 patients from the published institutional review board-approved, prospective, multi-centre, single-arm Phase I clinical trial of TULSA. Viable PV at 12 months was measured as the remaining PV on T2-weighted MRI, less 12-month NPV, scaled by the fraction of fibrosis in 12-month biopsy cores. Reduction of viable PV was compared to predictions based on the fraction of the prostate covered by the MR-t derived acute thermal ablation volume (ATAV, 55°C isotherm), delayed thermal ablation volume (DTAV, 240 cumulative equivalent minutes at 43°C thermal dose isocontour) and treatment-day NPV. We also report linear and volumetric comparisons between metrics.ResultsAfter TULSA, the median 12-month reduction in viable PV was 88%. DTAV predicted a reduction of 90%. Treatment day NPV predicted only 53% volume reduction, and underestimated ATAV and DTAV by 36% and 51%.ConclusionQuantitative volumetry of the TULSA phase I MR and biopsy data identifies DTAV (240 CEM43 thermal dose boundary) as a useful predictor of viable prostate tissue reduction at 12 months. Immediate post-treatment NPV underestimates tissue ablation.Key Points• MRI-guided transurethral ultrasound ablation (TULSA) achieved an 88% reduction of viable prostate tissue volume at 12 months, in excellent agreement with expectation from thermal dose calculations.• Non-perfused volume on immediate post-treatment contrast-enhanced MRI represents only 64% of the acute thermal ablation volume (ATAV), and reports only 60% (53% instead of 88% achieved) of the reduction in viable prostate tissue volume at 12 months.• MR-thermometry-based predictions of 12-month prostate volume reduction based on 240 cumulative equivalent minute thermal dose volume are in excellent agreement with reduction in viable prostate tissue volume measured on pre- and 12-month post-treatment T2w-MRI.

Purpose To assess the safety and efficacy of ultrasound coagulation of the ciliary body in refractory glaucoma. Methods This prospective multicenter interventional study was conducted in two Italian university-affiliated glaucoma centers: St. Orsola-Malpighi Teaching Hospital (Bologna, Italy) and University Eye Clinic of Genoa (Genoa, Italy). The main inclusion criterion was the diagnosis of glaucoma with a baseline intraocular pressure (IOP) ≥ 21 mmHg while on maximum topical and systemic medical hypotensive treatment. The EyeOP1 device (Eye Tech Care, Rillieux-la-Pape, France), which was employed in the study, uses miniaturized transducers to produce high-intensity focused ultrasound (HIFU). Treatment consisted of the sequential activation of each transducer lasting 4 s (group 1), 6 s (group 2) or 8 s (group 3). Hypotensive medications were interrupted after surgery and then prescribed only if postoperative IOP was ≥ 21 mmHg during follow-up visits. Patients were assessed before and 1, 7, 14, 30, 90 and 180 days after the procedure. Primary outcomes were the mean IOP reduction in the overall population and in groups 1, 2 and 3, and the rates of complete success, qualified success and failure. Results Thirty eyes (16 open-angle, 10 angle-closure and 4 neovascular glaucoma) of 30 patients were included. The mean preoperative IOP was 30.1 ± 10.5 mmHg. Twenty-nine patients completed the entire study follow-up; one patient exited from the study 3 months after HIFU and underwent trabeculectomy. At days 1 and 180, the mean IOP was significantly reduced (18.4 ± 7.2 and 20.2 ± 6.2 mmHg, respectively; all p  < 0.0001). Group 3 patients (8-s ultrasound exposure time) showed a greater IOP reduction than the other two groups (−16.2 ± 8.3 for group 3 vs. −8.8 ± 6.6 for group 2 and −3.7 ± 6.5 for group 1; p  = 0.02 and p  < 0.001, respectively). Qualified and complete success was achieved in 23.3 and 46.7% of patients, respectively; treatment failure was recorded in 6.6%. Conclusions Ultrasonic coagulation of the ciliary body is a safe and effective procedure for reducing IOP in refractory glaucoma. The increase in ultrasound exposure time appears to improve the response rate and the global efficacy of the procedure, with no detrimental effect on safety.

ObjectiveHigh-intensity focused ultrasound (HIFU) ablation is a promising treatment for benign thyroid nodules but single application is less effective in larger-sized nodules. We aimed to assess the efficacy and safety of two sequential applications in larger-sized nodules.MethodsFifty patients underwent ablation of a large-sized nodule (baseline volume ≥ 20 mL and diameter ≤ 50 mm). Thirty-one (62.0%) patients underwent single application (group I) while 19 (38.0%) underwent two sequential applications (group II). Nodule shrinkage (by volume reduction ratio or VRR), pain scores during and after ablation, and rate of vocal cord palsy (VCP), skin burn, and nausea/vomiting were compared between the two groups. t test or the Mann-Whitney U test was used for continuous variables while chi-square test was used for categorical variables. To determine factors for VRR, multivariate analysis was done by logistic regression analysis.ResultsTotal energy delivered and treatment time were significantly more in group II (p < 0.001 and p = 0.001, respectively). Total energy per nodule volume (kJ/mL) was also significantly greater in group II (1.01 kJ/mL vs. 0.57 kJ/mL, p < 0.001). The 6-month VRR was significantly greater in group II (56.74 ± 11.47% vs. 43.49 ± 12.03%, p = 0.004). Pain severity and rates of VCP, skin burn, and nausea/vomiting were comparable between the two groups (p > 0.05). Sequential application was an independent determinant of 6-month VRR (OR = 13.936, 95% CI = 1.738–197.399, p = 0.036).ConclusionsSequential application led to better 6-month treatment efficacy than single application in large-sized nodules. Patients undergoing sequential application are not at greater risks of treatment-related side effects afterwards.Key Points• Sequential application produces better 6-month efficacy over single application for large-sized nodules.• Sequential HIFU application is well-tolerated and safe in patients with large-sized nodules.• Sequential application takes longer and requires larger amount of pethidine and diazepam.

BackgroundProstate cancer focal therapy aims to minimize the side-effects of whole gland treatments, such as radical prostatectomy and radiotherapy without compromising oncological efficacy. However, concerns exist regarding the multifocal nature of prostate cancer and the lack of long-term oncological data for this form of treatment. In recent years, the routine adoption of multi-parametric magnetic resonance imaging (mpMRI) of the prostate has improved our ability to select candidates for focal therapy and to accurately deliver this form of prostate cancer treatment.MethodsWe performed a review of the literature to provide a summary of the oncological and functional outcomes of men receiving primary prostate focal therapy. Furthermore, we discuss the impact of the routine implementation of mpMRI as part of the initial prostate cancer diagnostic pathway on the selection of candidates and delivery of focal therapy. Finally, we summarize knowledge gaps in the field and highlight active clinical trials in this arena.ResultsPrimary focal therapy involves the application of one of a number of energies that ablate tissue, such as cryotherapy and high intensity focused ultrasound (HIFU). Success is principally dependent on highly accurate patient selection and disease localization underpinned in large part by the routine integration of pre-biopsy mpMRI. Prospective medium-term follow-up data for primary HIFU and cryotherapy for men with intermediate-risk disease have shown acceptable cancer control with low risk of side effects and complications. Additional research is needed to clearly define an appropriate follow-up approach and to guide the management of in- and out-of-field recurrences. Multiple comparative trials with randomization against standard care are currently underway in men with intermediate- and high-risk prostate cancer.ConclusionThe widespread adoption of prostate mpMRI has led to improved disease localization, enabling the performance of focal therapy as a viable treatment strategy for men with low volume intermediate-risk prostate cancer.

OBJECTIVES: High-intensity focused ultrasound (HIFU) is widely used to treat uterine fibroids. HIFU preoperative localization of uterine fibroids can be used to determine whether the patient is a suitable candidate for HIFU treatment. This study investigated the clinical significance of bladder training in improving the success rate of HIFU preoperative localization uterine fibroids. MATERIAL AND METHODS: Our sample consists of patients who planned to undergo HIFU treatment in our hospital but who were failed in previous HIFU preoperative localization. They were recruited between July 2021 and April 2022, and randomly divided into experimental and control groups. A total of 150 patients were enrolled. Each group consisted of 75 patients. The patients in the experimental group adopted the procedure of drinking water multiple times and retaining urine. The training program lasted three days. The patients in the control group were required to keep regular drinking and urination habits without any special instructions or requirements. RESULTS: There were no statistically significant differences between the two groups in maximum bladder capacity, residual urine volume of bladder, bladder filling levels, and bladder shape change. After bladder training, the maximum bladder capacity and the degree bladder shape change of the patients in the experimental group were improved significantly. The success rate of HIFU preoperative localization in the patients in the experimental group was significantly higher than that of the control group. CONCLUSIONS: Bladder training can effectively improve the success rate of HIFU preoperative localization of uterine fibroids.