Magnetic Resonance-guided Focused Ultrasound Surgery Research Articles

Authors' Reply

We would like to thank Dr Fennessy and colleagues for their comments regarding the use of MR-guided focused ultrasound surgery (MRgFUS) for the treatment of uterine fibroids; and furthermore, we would like to take the opportunity to respond to several of their comments. The original draft was written in the spring of 2009 but was only recently published in JACR [ 1 Burke C.T. Funaki B.S. Ray Jr, C.E. et al. ACR Appropriateness Criteria® on treatment of uterine leiomyomas. J Am Coll Radiol. 2011; 8: 228-234 Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar ]. The nature of all published literature is somewhat dated. An update of this topic was initiated this spring, including a review of the relevant published literature over the past 2 years and an update to the evidence table and narrative [ 2 American College of RadiologyACR Appropriateness Criteria topic review process—Interventional Radiology Panel. http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/Topic-Review-Process-Interventional-Radiology.aspx Google Scholar ]. Re: “ACR Appropriateness Criteria® on Treatment of Uterine Leiomyomas”Journal of the American College of RadiologyVol. 8Issue 9PreviewWe read with great interest the article by Burke et al [1] in the April 2011 issue of JACR that reported on recommendations for the treatment of uterine fibroids on the basis of evidence-based consensus of the ACR Appropriateness Criteria® Expert Panel on Interventional Radiology. Each treatment option was said to have been “discussed with consideration of outcomes, complications, and … cost-effectiveness.” However, we believe the discussion of MR-guided focused ultrasound surgery (MRgFUS) for treatment of uterine fibroids to be outdated. Full-Text PDF

Re: “ACR Appropriateness Criteria® on Treatment of Uterine Leiomyomas”

We read with great interest the article by Burke et al [1] in the April 2011 issue of JACR that reported on recommendations for the treatment of uterine fibroids on the basis of evidence-based consensus of the ACR Appropriateness Criteria® Expert Panel on Interventional Radiology. Each treatment option was said to have been “discussed with consideration of outcomes, complications, and … cost-effectiveness.” However, we believe the discussion of MR-guided focused ultrasound surgery (MRgFUS) for treatment of uterine fibroids to be outdated.

WE‐C‐220‐03: Lessons Learned: Creating a Dedicated Focused Ultrasound Surgery Program

MR‐guided focused ultrasound surgery (MRgFUS) is an emerging technology with the potential to disrupt traditional treatment techniques across a wide variety of surgical and medical disciplines. Proposed applications for MRgFUS are multiplying quickly and include indications as diverse as tumor ablation, thrombolysis, hemostasis, reversible blood‐brain barrier disruption, targeted drug delivery, gene therapy, and neuromodulation. Interest in MRgFUS is quickly increasing, however the desire to find new potential treatment indications may be outpacing work on developing “best practices” for designing new centers, organizing clinical teams, and defining standards for treatment quality and reporting. The University of Virginia recently started up one of the first programs in the world designed from the ground up specifically for the purpose of MR‐guided focused ultrasound surgery. The lessons learned during this process, both positive and negative, may be valuable to the ongoing discussion of best practices. This lecture will provide an overview of the UVA experience, including center design, construction, and administrative organization, and funding /revenue, and program startup. A particular focus will be on the clinical startup experience, and how this might be improved with a more formal risk‐based process analysis.Learning objectives:1. To understand the rationale for a stand‐alone FUS center versus a center created out of existing resources in the medical center.2. To understand the design features of the center, as well as the challenges that had to be overcome in the design and construction of the center.3. To understand the multidisciplinary organization of the center and how inter‐department conflicts are managed.4. To understand the expectations vs. reality of the center regarding the distribution of treatment indications, the effort required to start clinical trials, and the ability to collect clinical revenue.5. To understand the centerˈs experience during clinical startup, and the successes and challenges faced by the center when trying to refine clinical processes and develop standards for quality assurance.Funding Support, Disclosures, and Conflict of Interest: The Focused Ultrasound Center at the University of Virginia has received funding for development and research from the following: The Focused Ultrasound Surgery Foundation, the Commonwealth of Virginia, InSightec Ltd., and the General Electric Co.

Magnetic resonance-guided focused ultrasound surgery for leiomyoma-associated infertility

ObjectiveTo describe magnetic resonance-guided focused ultrasound surgery (FUS) as a treatment for a case of leiomyoma-associated infertility.DesignCase report from a randomized clinical trial.SettingAcademic medical center.Patient(s)A 37-year-old woman with known leiomyomas and a history of 18 months of home-inseminations from a known donor.Intervention(s)Magnetic resonance-guided FUS treatment of uterine fibroids, where the dominant fibroid distorted the uterine cavity.Main Outcome Measure(s)Pregnancy.Result(s)A viable intrauterine pregnancy, with a full-term vaginal delivery, was conceived after a single clomiphene citrate and intrauterine insemination cycle.Conclusion(s)The role of FUS for enhancement of fertility in women with nonhysteroscopically resectable uterine fibroids distorting the uterine cavity should be investigated further.

Successful Use of Magnetic Resonance-Guided Focused Ultrasound Surgery for Long-Term Pain Palliation in a Patient Suffering from Metastatic Bone Tumor

Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) is a non-invasive thermo-ablative technique for the treatment of various benign and malignant soft tissue and bone tumors, using focused ultrasound under real-time magnetic resonance imaging (MRI) guidance and control (1). This method of thermal ablation has proved effective in more than 5,000 uterine fibroid treatments and in more than 500 treatments of various other tumors (2). Recently, MRgFUS was tested for the palliation of pain caused by bone metastases, utilizing the acoustic properties of bone for absorption of ultrasonic energy to achieve palliation and has yielded very promising initial results (3, 4). Applying acoustic energy on the bone surface allows the creation of temperature rise in the part of the bone cortex enclosed in the beam path zone, thus indirectly ablating the adjacent periosteum and tumor tissue (4). Since the periosteum is considered to be a major source of pain in patients with metastatic bone lesions, ablating the source of pain should produce lasting pain relief. High absorption of energy in the bone allows using lower energies (compared to soft tissue MRgFUS treatment), thereby enhancing the safety profile of this procedure. Thus, MRgFUS offers a novel, alternative treatment option for painful bone metastases. The present report briefly discusses the successful use of Case Report pISSN 1738-2637 J Korean Soc Radiol 2011;65(2):133-138

Spontaneous Vaginal Expulsion of Uterine Myoma after Magnetic Resonance–Guided Focused Ultrasound Surgery

Uterine myomas are common benign uterine tumors in women of reproductive age. Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is a minimally invasive procedure that produces coagulative necrosis at a precise focal point within the body. MRgFUS regarded as an effective and safe treatment modality in women with symptomatic uterine myomas. Vaginal passage of treated myoma tissue has been reported during other therapeutic procedures such as uterine artery embolization or during puerperium. This study is the first to report a case of vaginal expulsion of uterine myoma after MRgFUS, with complete endometrial recovery on follow-up.

Résultats préliminaires de la destruction des fibromes utérins par ultrasons focalisés contrôlée par résonance magnétique

Objective Many women with myomas desire uterine conservation. Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is a new non-invasive therapy. We describe our early results regarding efficacy and safety of MRgFUS for the treatment of uterine leiomyomas. Patients and methods Fifty-two French women, over 18 years of age, who were candidates for surgical myomectomy, hysterectomy or uterine artery embolization due to symptomatic myomas were treated by MRgFUS (ExAblate 2000 ®, InSightec) and followed up for at least 6 months. Intramural or subserous myomas with a size between 4–12 cm and a T2 low intensity MRI image were selected in women with no abdominal scar and no bowel interposition. The modified symptom severity score (SSS) was examined before and after the treatment at 6 months. Second treatment rate during the first follow-up year was reported. Results No serious complications were recorded during the treatments or follow-up period. Seven women had initial failure mostly because of bowel interposition, six of them had uterine artery embolisation. The mean modified SSS value for patients before MRgFUS was 41/100 and the values diminished significantly to a mean value of 22/100. A total of 65% of women had a reduction of at least 10 points ( n = 22) (initial score of 41 [29; 62] and 22 [16; 46] at 6 month follow-up). Good correlation was observed between myomas destruction and the symptoms score. During the follow-up period, ten patients (19%) required invasive interventions (six hysterectomies, two embolisations and two myomectomies). The average reduction in myoma volume determined by MR imaging at 6 months after treatment was 14%. This volume reduction is poorly correlated with the myoma's treated volume of 36.4% (6–74%). Conclusion MRgFUS can safely be used for symptomatic treatment and avoid the need for surgical intervention in most patients. Additional follow-up is needed to determine the long-term durability of this promising non-invasive approach and to obtain reimbursement.

Short-term results of magnetic resonance imaging-guided focused ultrasound surgery for patients with adenomyosis: symptomatic relief and pain reduction

The objective of this study was to evaluate the degree of symptomatic relief obtained after treatment with magnetic resonance-guided focused ultrasound surgery in patients with adenomyosis. Quality of life and pain assessment questionnaires from 35 women, collected on the day of treatment and up to 6 months after treatment, indicated that the treatment was safe and there was a significant reduction in symptoms.

High-intensity focused ultrasound ablation of uterine localized adenomyosis

To introduce recent developments in a noninvasive treatment of using high-intensity focused ultrasound (HIFU) for ablating uterine localized adenomyosis, and to discuss their potential in this application. This literature roughly reviewed conservative therapy for uterine localized adenomyosis and emphasized using HIFU for ablating it. The main histological change of HIFU treatment was the coagulative necrosis of adenomyosis cells, with damage on small blood vessels of adenomyoma. MR-guided focused ultrasound surgery (MRgFUS) and ultrasound-guided HIFU ablation of focal adenomyosis were with satisfactory results. MRgFUS was less invasive and safely ablated adenomyosis tissue close to the endometrium or to serosal surface. HIFU might be safe and effective for treating patients with adenomyosis, and the acoustic intensity was a key factor for therapeutic efficacy as the severity of symptoms might correlate with lesion extent in some patients. At a given therapeutic dose, the influence of acoustic intensity on focal temperature rise was greater than that of exposure time. Some other experiments showed that the size of adenomyoma was increased 3-4 months after HIFU treatment. The reasons were related to the size of tumor, treatment parameters, operation procedure, and the blood supply of the targeted tissue. Although recent results have been very encouraging, further trials are essential to evaluate the long-term efficacy, and cost-effectiveness of HIFU ablation in localized adenomyosis. Compared with current conservative treatments, HIFU may be a noninvasive approach and may offer complete ablation of adenomyoma, with less trauma, less complication, and low cost and short hospital stay for treating patients with uterine localized adenomyosis.

Pregnancy Outcome After Magnetic Resonance-Guided Focused Ultrasound Surgery for Conservative Treatment of Uterine Fibroids

Uterine fibroids (leiomyomata)—the most common tumors of the female reproductive tract—are associated with impaired fertility and specific complications of pregnancy. The fibroids are found in 20% to 25% in reproductive-age women. Surgical myomectomy is the treatment of choice for women who wish to remain fertile and there is long experience with this procedure. In some patients, however, rare but serious complications have been reported with surgical approaches. Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is a noninvasive myomaspecific treatment for symptomatic uterine fibroids that employs coagulative necrosis to destroy leiomyoma tissue. More than 4000 women have undergone MRgFUS globally, and the procedure has been reported to be safe and effective. This preliminary report reviews the outcome data of all known pregnancies occurring after MRgFUS recorded in a prospective registry maintained by the manufacturer and reported to the Food and Drug Administration. The database contains information on pregnancy outcomes from 13 sites in 7 countries. Outcome data were examined from 54 pregnancies of 51 mothers who had undergone MRgFUS treatment for symptomatic uterine leiomyomas. The mean time to pregnancy after the procedure was 8 ± 7 months (range, 0-30 months). Of the 54 pregnancies, 22 (41%) resulted in live births and 11 (20%) were ongoing >20 weeks. The spontaneous abortion rate was 27% and the rate of therapeutic abortion was 11%. The mean birth weight was 3.3 kg and 64% of the women had a vaginal delivery. These findings demonstrate that both normal vaginal deliveries and outcomes are possible following MRgFUS, which is reassuring information for pregnant women who wish to conceive after the procedure.

Non-Surgical Treatment Options for Symptomatic Uterine Leiomyomas

Uterine leiomyomas (or uterine fibroids), benign tumors of the uterine smooth muscle cells, can cause significant morbidity and impair quality of life in many women. For those who are asymptomatic, watchful waiting constitutes appropriate management. For women with symptomatic fibroids, hysterectomy and myomectomy are traditionally the standard treatments. In the last two decades, many alternatives to surgery for the management of fibroids have been developed. Most of the current medical treatments involve hormone manipulation. Newer treatments such as mifepristone, asoprisnil and aromatase inhibitors show promising results in fibroid symptom and size reduction; however, larger studies are needed. A safe and effective therapy as an alternative to hysterectomy is uterine artery embolization (UAE), which offers shorter recovery times and fewer major complications, though fertility and pregnancy outcomes after a UAE may be affected. Limited data are available for the efficacy and safety of temporary uterine artery occlusion. Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is the newest treatment option for uterine fibroids. It also shows promising results for symptom relief. The degree of symptom relief depends significantly on the amount of fibroid volume that is non-perfused after treatment and the experience of the physician performing the procedure. Keywords: Fibroids, hormones, NSAIDs, progestins, oral contraceptives, mifepristone, asoprisnil, gonadotropin-releasing hormone agonists, uterine artery embolization, selective estrogen receptor modulators, transvaginal temporary uterine artery occlusion, magnetic resonance-guided focused ultrasound surgery

Magnetic Resonance-Guided Focused Ultrasound Surgery

Magnetic resonance guided focused ultrasound surgery (MRgFUS) is a noninvasive thermoablative therapy that was approved by the Food and Drug Administration in 2004 for the treatment of uterine fibroids (leiomyomas). Data on safety and long-term efficacy are accumulating to establish the unique usefulness of this therapy in targeting and treating leiomyomas through the integration of MR imaging. This article describes the established thermoablative therapies in the treatment of uterine fibroids, emphasizing their role in the genesis of MRgFUS. Treatment specifications are highlighted, and an overview of the procedure is given. Data from both clinical trials and commercial treatments are detailed for multiple efficacy outcomes, including symptom improvement, leiomyoma shrinkage, and use of alternative procedures. The concept of nonperfused volume as a surrogate marker for treatment success is discussed. Importantly, favorable pregnancy outcomes following MRgFUS have been reported. Applications of MRgFUS have recently expanded into the realm of adenomyosis treatment. MRgFUS has been deemed a safe and effective method of fibroid treatment and offers the advantages of no incisions or blood loss, speedy recovery, and a cost-effective means of treatment.

Magnetic resonance-guided focused ultrasound surgery (MRgFUS) treatment for uterine fibroids

Magnetic Resonance-guided focused Ultrasound Surgery (MRgFUS) is gaining popularity as an alternative to medical and surgical interventions in the management of symptomatic uterine fibroids. Studies have shown that it is an effective non-invasive treatment with minimal associated risks as compared to myomectomy and hysterectomy. MRgFUS can be offered to a majority of patients suffering from symptomatic uterine fibroids. It has been suggested that the use of broader inclusion criteria as well as the mitigation techniques makes it possible to offer MRgFUS to a much larger subset of patients than previously believed. This paper will describe how MRgFUS treatment for uterine fibroids is performed at the University of Malaya Medical Centre, Kuala Lumpur, Malaysia.

Magnetic-resonance-guided Focused Ultrasound Surgery in the Treatment of Oncology Patients — Fundamentals and Review of Early Clinical Applications

Magnetic-resonance-guided focused ultrasound surgery (MRgFUS) is a novel non-invasive surgical procedure in the field of image-guided interventions. Thermal ablation is achieved using focused ultrasound beams controlled by magnetic resonance. Energy delivered to focal (sonication) spots allows for a very precise and controlled increase in temperature, resulting in coagulative necrosis of target tissue. 3D visualisation and temperature monitoring allow for realtime feedback and control. Post-treatment evaluation is performed in the same session. Since there is no dose limit, the procedure can be repeated as needed. An expanding number of applications are currently being developed in oncology. This article reviews the fundamentals and initial clinical data, including palliative treatment of pain in bone metastases, breast cancer, diseases of the central nervous system, prostate cancer, hepatocellular carcinoma and targeted drug delivery.

High intensity focused ultrasound ablation: A new therapeutic option for solid tumors

Surgery has been the standard of care in selected cases with solid tumors. However, a majority of patients are unable to undergo surgical resection because of the tumor sites, advanced stages, or poor general condition. High intensity focused ultrasound (HIFU) is a novel non-invasive technique that is capable of producing coagulative necrosis at a precise focal point within the body, without harming overlying and adjacent structures even within the path of the beam. Diagnostic ultrasound was the first imaging modality used for guiding HIFU ablation in the 1990 s. Over the last decade, thousands of patients with uterine fibroids, liver cancer, breast cancer, pancreatic cancer, bone tumors, renal cancer have been treated with ultrasound imaging-guided HIFU (USgHIFU) worldwide. This USgHIFU system [Chongqing Haifu (HIFU) Tech Co., Ltd., Chongqing, China] was first equipped in Asia, now in Europe. Several research groups have demonstrated that HIFU is safe and effective in treating human solid tumors. In 2004, the magnetic resonance guided focused ultrasound surgery (MRgFUS) was approved by the United States Food and Drug Administration (FDA) for clinical treatments of uterine fibroids. We conclude that HIFU offers patients another choice when no other treatment available or when patients refused surgical operation. This technique may play a key role in future clinical practice.

Magnetic Resonance Image Guided Focused Ultrasound Surgery of Early Breast Cancer: Efficacy and Safety in Excisionless Study.

Abstract Background: The prognosis of the breast cancer patient doesn't depend on the local treatment, but on the systemic treatment. Breast conserving therapy, lumpectomy following radiotherapy, has been proved to be as good as mastectomy in several clinical trials. When focused ultrasound waves propagate in tissue, the energy is absorbed and converted to heat, resulting in tissue coagulation. MRI is the best modality in spatial resolution for the detection of breast cancer spread. Two phase II clinical studies (excision studies) to investigate pathological efficacy and clinical safety of MR guided focused ultrasound surgery (MRgFUS) were conducted and their outcome has been published.Purpose: The purpose of this study is to inspect the efficacy and safety of MRgFUS as a local treatment for early breast cancer followed by radiotherapy in a phase III study.Methods: The inclusion criteria include 1) tumor diagnosis by core needle biopsy under ultrasound 2) HER-2,HR status confirmation 3) tumor size is less than 15mm in diameter, 4) well demarcated mass in contrast enhanced MRI. The exclusion criteria include 1) pure type mucinous carcinoma, 2) invasive micropapillary carcinoma, 3)skin dimple or dimpling sign, previous surgical scar of the skin above the tumor, 4) location of the tumor requires a high sonication angle. Core needle biopsy was performed again within three weeks after ablation and no residual viable cancer cells were identified by HE stain and single strand DNA immunohistochemical stein. The following radiotherapy is whole breast(50Gy) and boost(10Gy). Results: Fifty patients entered this study and forty-one lesions were completely treated from April 2005 to June 2009. The median age was 57 years old (37 - 72). The average tumor size was 11.0mm (6 - 15). The median follow up period was 29 months (1 - 48). Thirty five cases were followed up for more than 12 months. There were no severe adverse events and no local recurrence cases.Conclusions: Although the number of cases is still small and the follow-up period is short, MRgFUS has the potential of replacing usual breast conserving surgery. Strict selection of cases is essential. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 4126.

MR imaging FOLLOW UP after MR-guided Focused Ultrasound Surgery for uterine leiomyomas — Early and mid term results

Abstract Rationale and Objectives: MR-guided Focused Ultrasound Surgery (MRgFUS) is an evolving thermoablative technique for treatment of benign and malignant soft tissue tumors. The feasibility and effectiveness of this non-invasive method has been tested by several investigators by treating uterine fibroid. The aim of the present study was to evaluate early and mid-term efficacy of MRgFUS treatment using MR imaging follow-ups. Materials and Methods: 38 patients with uterine fibroids were enrolled and treated by MRgFUS in a single center. MRI follow-up exams were performed 3 and 6 months after the procedure. Total fibroid volumes (FV) and non-perfused volumes (NPV) were compared and evaluated over time. Results: There was a significant reduction of FV at 3- and 6-month follow-ups (10±19%, p=0.022 and 19±29%, p<0.001, respectively). In the subgroup of fibroids smaller than 5.4 cm in diameter a 35±18% volume reduction was found after 6 months. There was also a positive correlation found between the early NPV and the FV decrease at 3- and 6-months follow-ups. Conclusion: This study suggests that MRgFUS can effectively coagulate uterine fibroid tissue. Smaller UFs can be most effectively treated within reasonable time with the used equipment.

Clinical outcomes of magnetic resonance‐guided focused ultrasound surgery for uterine myomas: 24‐month follow‐up

To assess the volume reduction ratio, symptom improvement and reintervention rate following magnetic resonance-guided focused ultrasound surgery (MRgFUS) for uterine myomas. A total of 91 Japanese women with symptomatic myomas underwent MRgFUS between June 2004 and June 2008 using the ExAblate 2000 system. The volume change ratio was calculated at 6, 12 and 24 months following MRgFUS based on T2-weighted magnetic resonance images. The symptom severity score (SSS) was examined before and after the treatment (at 3, 6, 12 and 24 months). Additional post-MRgFUS treatments, such as hysterectomy, myomectomy, uterine artery embolization or repeat MRgFUS, were recorded and the reinterventional treatment rates were compared according to the signal intensity of pretreatment T2-weighted magnetic resonance images of the myomas. The mean volume change ratios of low- and intermediate-intensity (Type 1/2) myomas were -36.5% 6 months post-procedure and -39.5% 24 months post-procedure. The mean +/- SD SSS value for patients with Type 1/2 myomas before MRgFUS was 35.1 +/- 21.0, and the values diminished significantly during the 24-month follow-up period to a mean value of around 15.0. High-intensity (Type 3) myomas were not observed to have decreased in size 6 months after MRgFUS. Of the 45 Type 1/2 myoma patients with complete follow-up, seven required reinterventional treatment within 24 months. The reintervention rates were 14.0% for Type 1/2 patients and 21.6% for Type 3 patients at 24 months post-treatment. Moderate volume reductions of Type 1/2 myomas were noted following MRgFUS, and the reduction in SSS values and the relatively low reintervention rates observed are encouraging. We found MRgFUS to be an appropriate treatment method for Type 1/2 uterine myomas.

Non‐invasive magnetic resonance‐guided focused ultrasound treatment of uterine fibroids in a large Japanese population: impact of the learning curve on patient outcome

To describe the learning curve effect of magnetic resonance-guided focused ultrasound surgery (MRgFUS) on the outcomes of patients treated for uterine fibroids in four centers in Japan. The extent of fibroid ablation (often used to measure treatment success) was evaluated using the non-perfused volume (NPV) ratio in 287 Japanese patients. The patients were divided into two equal groups according to the chronological treatment time and results were compared between these groups to estimate the learning curve effect. Results were also compared with published data from clinical trials. The NPV ratio increased chronologically, from 39.3% to 54.0% (P < 0.001), indicating increasing effectiveness of the treatment with experience. The mean NPV ratios for the entire patient population were over double that of previous clinical trials (46.6% vs. 21.9%; P < 0.001). No serious complications were reported. The learning process and accumulation of data on MRgFUS enable the optimization of treatments in order to safely achieve large NPV ratios and sustained clinical benefit.

P27.04: Ablation of uterine adenomyosis by magnetic resonance guided focused ultrasound surgery (MRgFUS)

We investigated the feasibility of ablating uterine adenomyosis by MR-guided focused ultrasound surgery (MRgFUS) and any adverse events that may arise during, immediately after and 1-week after MRgFUS. The subjects were 40 women with symptomatic adenomyosis, who had completed their family planning. The clinical trial was approved by the Ethics Committee of our hospital. The patients were treated by MRgFUS, a system comprising ExAblate 2000 (InSightec Israel), that generates high intensity focused ultrasound beams, and MRI, that provides real-time visualization of patient anatomy and temperature changes in and around the treated area. The treatment was applied to an area a few millimeters inside the adenomyosis as done in myoma treatment. After treatment, the non-perfused area and ablation result were evaluated through contrast enhanced T1-weighted MR images. Seventeen patients with extensive adenomyosis underwent a second treatment for the remnant lesion. Adverse events were examined during the treatment and one week after MRgFUS. Temperature rise of 60 °C to 90 °C was recorded in the sonicated region of the adenomyosis, and almost all the patients reported mild to moderate pain during the procedure. One patient unable to tolerate pain did not complete the treatment. The architecture at the periphery of the non-perfused area on sagittal view of MR images after the treatment was almost round (type R) in 28 patients, serrated in 7 (type S) and honeycombed (type H) in 4. Type R was considered well ablated, leaving no perfused lesion in the targeted tissue. Watery and thin bloody discharge was often reported by patients at their 1-week follow-up visit. Most of the patients were able to return to work within 3 days of the treatment. The adenomyosis tissue was ablated by MRgFUS, without severe complications. This method for treatment of uterine adenomyosis is promising at this first stage of tissue ablation.