Yael Inbar

Magnetic Resonance–Guided Focused Ultrasound for Patients With Painful Bone Metastases: Phase III Trial Results

Background Pain due to bone metastases is a common cause of cancer-related morbidity, with few options available for patients refractory to medical therapies and who do not respond to radiation therapy. This study assessed the safety and efficacy of magnetic resonance-guided focused ultrasound surgery (MRgFUS), a noninvasive method of thermal tissue ablation for palliation of pain due to bone metastases. Methods Patients with painful bone metastases were randomly assigned 3:1 to receive MRgFUS sonication or placebo. The primary endpoint was improvement in self-reported pain score without increase of pain medication 3 months after treatment and was analyzed by Fisher’s exact test. Components of the response composite, Numerical Rating Scale for pain (NRS) and morphine equivalent daily dose intake, were analyzed by t test and Wilcoxon rank-sum test, respectively. Brief Pain Inventory (BPI-QoL), a measure of functional interference of pain on quality of life, was compared between MRgFUS and placebo by t test. Statistical tests were two-sided. Results One hundred forty-seven subjects were enrolled, with 112 and 35 randomly assigned to MRgFUS and placebo treatments, respectively. Response rate for the primary endpoint was 64.3% in the MRgFUS arm and 20.0% in the placebo arm (P < .001). MRgFUS was also superior to placebo at 3 months on the secondary endpoints assessing worst score NRS (P < .001) and the BPI-QoL (P < .001). The most common treatment-related adverse event (AE) was sonication pain, which occurred in 32.1% of MRgFUS patients. Two patients had pathological fractures, one patient had third-degree skin burn, and one patient suffered from neuropathy. Overall 60.3% of all AEs resolved on the treatment day. Conclusions This multicenter phase III trial demonstrated that MRgFUS is a safe and effective, noninvasive treatment for alleviating pain resulting from bone metastases in patients that have failed standard treatments.

Magnetic resonance‐guided focused ultrasound (MRgFUS) compared with abdominal hysterectomy for treatment of uterine leiomyomas

To compare women undergoing magnetic resonance‐guided focused ultrasound (MRgFUS) to a group of contemporaneously recruited women undergoing total abdominal hysterectomy. Patient demographics, safety parameters, quality of life outcomes and disability measures are reported.

Magnetic resonance-guided focused ultrasound surgery (MRgFUS). Four ablation treatments of a single canine hepatocellular adenoma

BACKGROUND Canine hepatocellular adenomas are benign, well-differentiated, primary hepatic tumors. Surgical resection is technically demanding and is considered a major procedure with relatively high morbidity rates. Magnetic resonance-guided focused ultrasound surgery (MRgFUS) uses focused ultrasonic energy to non-invasively create a heat-coagulated lesion deep within the body. This effect can be achieved in a controlled, accurate manner. The aim of this study was to evaluate the safety, accuracy and efficacy of non-invasive focal ablation of tissue volumes of a canine benign liver tumour by consecutive MRgFUS sonications. MATERIALS AND METHODS Four MRgFUS procedures were performed in a 10-year-old, male, mixed large breed dog (45 kg) under general anaesthesia. The exact location and volume of the ablated areas were planned on the MR images. Real-time MR imaging and temperature mapping enabled the immediate evaluation of the effect of each sonication. Different areas were chosen within the tumour. These volumes of tumoral tissue were ablated by multiple sonications. To allow accurate targeting and quality imaging, sonications were performed during 20-30 s of apnoea. Between the sonications the dog was normally ventilated. The dog was operated 21 days after the fourth ablative procedure. The tumour was resected and histopathologically examined. RESULTS The MRgFUS created necrosis with contiguous areas of complete tissue destruction within the liver tumour, in full accordance with the planning. A focal thermal injury to the cartilage of the right lower ribs was noted after the fourth treatment. This lesion became infected and was treated surgically. Ten months after the last treatment the dog is well and healthy. CONCLUSIONS Focused ultrasound ablation of liver tumoral tissue with MR guidance under general anaesthesia and controlled apnoea is a safe and accurate treatment modality. Its main advantage is that it is a completely non-invasive image-guided treatment. The ablation of significant volumes of a highly vascular liver tumoral tissue was achieved. Such tissue can be ablated in a very accurate manner, exactly according to the pretreatment planning on the MR images. The MR imaging characteristics, including real-time temperature mapping, enable real-time control of every step of the ablation process. Mechanical ventilation with intermittent apnoea periods overcomes the problem of the respiratory movements of the liver. Care must be taken to avoid the passage of the ultrasound beam through energy-absorbing calcified tissue.

Magnetic resonance-guided focused ultrasound treatment of facet joint pain: summary of preclinical phase

Study designA phantom experiment, two thermocouple experiments, three in vivo pig experiments, and a simulated treatment on a healthy human volunteer were conducted to test the feasibility, safety, and efficacy of magnetic resonance-guided focused ultrasound (MRgFUS) for treating facet joint pain.ObjectiveThe goal of the current study was to develop a novel method for accurate and safe noninvasive facet joint ablation using MRgFUS.Summary of background dataFacet joints are a common source of chronic back pain. Direct facet joint interventions include medial branch nerve ablation and intra-articular injections, which are widely used, but limited in the short and long term. MRgFUS is a breakthrough technology that enables accurate delivery of high-intensity focused ultrasound energy to create a localized temperature rise for tissue ablation, using MR guidance for treatment planning and real-time feedback.MethodsWe validated the feasibility, safety, and efficacy of MRgFUS for facet joint ablation using the ExAblate 2000® System (InSightec Ltd., Tirat Carmel, Israel) and confirmed the systems ability to ablate the edge of the facet joint and all terminal nerves innervating the joint. A phantom experiment, two thermocouple experiments, three in vivo pig experiments, and a simulated treatment on a healthy human volunteer were conducted.ResultsThe experiments showed that targeting the facet joint with energies of 150–450 J provides controlled and accurate heating at the facet joint edge without penetration to the vertebral body, spinal canal, or root foramina. Treating with reduced diameter of the acoustic beam is recommended since a narrower beam improves access to the targeted areas.ConclusionsMRgFUS can safely and effectively target and ablate the facet joint. These results are highly significant, given that this is the first study to demonstrate the potential of MRgFUS to treat facet joint pain.

Checkmark: A sign for the detection of iliopsoas pathology on MRI of the hip

Background: The iliopsoas compartment can be involved in many different disease processes with a wide variety of symptoms that may simulate avascular necrosis (AVN) of the femoral head. The psoas muscle merges with the iliacus to form a checkmark (√) shape in the coronal MRI plane, with normal muscle intensities, on both sides of the spine. Purpose: To evaluate whether abnormality of this checkmark shape (obliteration or abnormal intensity), the checkmark sign, can be used as a simple indicator of iliopsoas pathologies on MR examinations performed for suspected AVN of the hip. Material and Methods: A total of 75 hip MRI examinations performed during 2007 for suspected AVN (male:female ratio, 44:31; average age, 41 years) were retrospectively assessed. The iliopsoas compartment was assessed on the coronal T1 and T2 fat saturated sequences for the presence of the checkmark sign by a consensus of two readers. Results: Twenty-six patients had signs of AVN and 49 patients had either other hip findings or normal hips. A normal checkmark shape was observed in all but two examinations. Obliteration of the checkmark shape, a positive checkmark sign, in those two was due to psoas compartment pathology (infection and hematoma of the iliopsoas compartment). Conclusion: A positive checkmark sign (abnormal shape or intensity) can serve as a clue for unsuspected iliopsoas pathology when evaluating MRI of the hip in patients with suspected AVN.

Outcome of magnetic resonance–Guided focused ultrasound surgery (MRgFUS) for FIGO class 1 fibroids

OBJECTIVE Intracavitary uterine fibroids and fibroids that distort the uterine cavity are associated with excessive vaginal bleeding and infertility. While intracavitary fibroids smaller than 4 cm are usually treated safely by operative hysteroscopy, larger fibroids may require multiple surgeries or more extensive surgery with possible damage to the integrity of the uterine wall. Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is a noninvasive approach for treating uterine fibroids, mainly the intramural type. We present the outcome of MRgFUS treatment for intracavitary fibroids (FIGO class 1) in cases that could not be treated by hysteroscopy due to either fibroid size or patient refusal. (Canadian Task Force II-1). STUDY DESIGN A retrospective cohort study from a single tertiary referral center. A total of 68 patients were treated by MRgFUS for symptomatic uterine fibroids from January 2013 to December 2016. Six of them had FIGO class 1 fibroids. Adverse effects and short- and long-term outcomes (quality of life issues and need for additional surgical intervention) were assessed during ambulatory clinic visits and by phone interviews. RESULTS The mean ± SD fibroid volume on MRI screening was 86.3 ± 60.9 cm3. Six of those patients underwent the procedure (mean age 40.5 ± 5.6 years, range 33-48). The follow-up duration was 24.1 ± 12.0 months. Four patients were not interested in future fertility and did not undergo additional treatment, while the two who planned to conceive underwent another surgical intervention (one underwent operative hysteroscopy after reduction of fibroid size and the other underwent laparoscopic myomectomy). CONCLUSION This preliminary study shows that MRgFUS can be a feasible treatment option for FIGO class 1 uterine fibroids. Shrinkage of fibroids by MRgFUS can obviate or facilitate subsequent surgical intervention in selected cases.

Splenic Pregnancy: A New Minimally Invasive Approach to Treatment.

The spleen is a rare site of abdominal ectopic pregnancy. In a review of the literature, we found 16 published cases of primary splenic pregnancies. Of the cases identified, all received surgical intervention, with one case successfully treated with laparoscopic methotrexate injection, and the rest underwent splenectomy. We would like to present a case of primary splenic pregnancy in a 35-year-old woman successfully treated with percutaneous image-guided injection of methotrexate and KCl.

Ciliated hepatic foregut cyst with high intra-cystic carbohydrate antigen 19-9 level

A ciliated hepatic foregut cyst (CHFC) is a rare foregut developmental malformation usually diagnosed in adulthood. Five percent of reported cases of CHFC transform into squamous cell carcinoma. We report the presentation, evaluation, and surgical management of a symptomatic 45-year-old male found to have a 6.2 cm CHFC. Contrast tomography-guided fine-needle aspiration demonstrated columnar, ciliated epithelium consistent with the histologic diagnosis of CHFC. The intracystic levels of carbohydrate antigen (CA) 19-9 and carcinoembryonic antigen (CEA) were extremely high (978118 U/mL and 973 μg/L, respectively). Histologically, the wall of the cyst showed characteristic pseudopapillae lined with a ciliated stratified columnar epithelium, underlying smooth muscle, an outer fibrous layer and no atypia. Immunohistochemistry for CA19-9 and CEA was positive. This is the first case report of a CHFC in which levels of CA 19-9 and CEA were measured. Our findings suggest that a large sized multilocular cyst and elevated cyst CA19-9 and CEA levels do not exclude a CHFC from consideration in the diagnosis. CHFCs should be included in the differential diagnosis of hepatic lesions. Accurate diagnosis of a CHFC is necessary given its potential for malignant transformation, and surgical excision is recommended.

Long-Term Urinary Bladder Function Following Unilateral Refluxing Low Loop Cutaneous Ureterostomy

Purpose Unilateral low loop cutaneous ureterostomy (LLCU) has been offered as the preferred method of temporary urinary diversion in cases of massively dilated and refluxing ureters. We sought to explore whether LLCU is effective in preserving urinary bladder function in the long term. Materials and Methods The charts of all patients who had undergone temporary unilateral LLCU as newborns in the presence of massive vesico-ureteric reflux were retrospectively reviewed. Demographic data, follow-up length, and presence of incontinence were recorded. Patients were interviewed regarding lower urinary tract symptoms (LUTS), and their urination patterns were recorded by using uroflow and post-void residual (PVR) measurements. Results Between 1972 and 2003, a total of 24 patients underwent unilateral LLCU in the presence of massively refluxing ureters. Eight patients were included in the final analysis. The median age at diversion was 12 days, the median time to closure was 22.5 months, and the median follow-up was 12.5 years. Urinary bladders showed normal contour, normal capacities, and minimal PVRs in most cases. None of the patients required augmentation cystoplasty. One patient suffered from urinary leakage and few demonstrated minimal LUTS. Conclusions Unilateral refluxing LLCU is an effective method of urinary diversion that preserves urinary bladder function for the long term. Larger studies are required to confirm this finding.

Abdominal computed tomography (CT) scan in the evaluation of refractory puerperal fever: impact on management

Abstract Introduction: Computed tomography (CT) imaging should be employed judiciously, given its cost, use of intravenous contrast, and ionizing radiation. The aim of this study was to determine the clinical benefit of a CT scan in the evaluation of refractory puerperal fever and to identify the appropriate candidates for its use. Methods: This was a retrospective cohort study conducted in a single tertiary care center between January 2007 to April 2017. Indications for CT scan were refractory postpartum fever of ≥3 days and/or ultrasound findings suggesting complex abdominal fluid collection. Primary outcome was defined as a change in the mode of treatment due to the CT findings. In addition, a multivariate analysis of risk factors for puerperal fever was performed to identify patients who would benefit from the CT scan evaluation. Results: There were 520 women that underwent an abdominal and pelvic CT scan during the study period, 238 (45.7%) met inclusion criteria, 94 (39.5%) had a normal CT scan, and 144 (60.5%) had abnormal findings including 32 (13.4%) cases with pelvic thrombophlebitis and 112 (47%) cases with pelvic fluid collections. Results of the CT changed clinical management in 93 (39.0%) patients, including: switching antibiotics in 24 (10%) patients, adding low molecular weight heparin for 28 (11.8%) patients, and surgical intervention (laparotomy or drainage insertion) in 41 (17.2%) patients. In the regression model, we didn’t find any significant risk factors associated with treatment change following the CT scan. Conclusions: Abdominal and pelvic CT scan in women with refractory puerperal fever has a high clinical yield and lead to a change in management in a substantial number of patients.