Focused ultrasound treatment of uterine fibroid tumors: Safety and feasibility of a noninvasive thermoablative technique

Stewart, Elizabeth A.; Gedroyc, Wladyslaw; Tempany, Clare M.; Quade, Bradley J.; Inbar, Yael; Ehrenstein, T.; Shushan, Asher; Hindley, Jonathan T.; Goldin, Robert; David, Matthias; Sklair, Miri; Rabinovici, Jaron

doi:10.1067/mob.2003.345

Cited by 397 publications

(246 citation statements)

References 17 publications

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“…Other groups are also generating results in different areas; an MRI-guided extracorporeal HIFU device (Exablate, Insightec Inc., Haifa, Israel) has been granted FDA approval for the treatment of uterine fibroids (Stewart et al, 2003), and trans-rectal HIFU devices are increasingly being used to treat localised prostate cancer in Europe (Blana et al, 2004).…”

Section: Kidneymentioning

confidence: 99%

The safety and feasibility of extracorporeal high-intensity focused ultrasound (HIFU) for the treatment of liver and kidney tumours in a Western population

et al. 2005

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High-intensity focused ultrasound (HIFU) provides a potential noninvasive alternative to conventional therapies. We report our preliminary experience from clinical trials designed to evaluate the safety and feasibility of a novel, extracorporeal HIFU device for the treatment of liver and kidney tumours in a Western population. The extracorporeal, ultrasound-guided Model-JC Tumor Therapy System (HAIFUt Technology Company, China) has been used to treat 30 patients according to four trial protocols. Patients with hepatic or renal tumours underwent a single therapeutic HIFU session under general anaesthesia. Magnetic resonance imaging 12 days after treatment provided assessment of response. The patients were subdivided into those followed up with further imaging alone or those undergoing surgical resection of their tumours, which enabled both radiological and histological assessment. HIFU exposure resulted in discrete zones of ablation in 25 of 27 evaluable patients (93%). Ablation of liver tumours was achieved more consistently than for kidney tumours (100 vs 67%, assessed radiologically). The adverse event profile was favourable when compared to more invasive techniques. HIFU treatment of liver and kidney tumours in a Western population is both safe and feasible. These findings have significant implications for future noninvasive image-guided tumour ablation.

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Section: Kidneymentioning

confidence: 99%

The safety and feasibility of extracorporeal high-intensity focused ultrasound (HIFU) for the treatment of liver and kidney tumours in a Western population

et al. 2005

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“…Pretreatment patient preparation, treatment planning, and sonication have been described in detail in previous publications (1)(2)(3)(4)(5)(6)(7). For planning on the day of treatment, standard T2-weighted fast spin-echo images were acquired while the patient was in the prone position on the MR-guided focused ultrasound surgery table.…”

Section: Treatmentmentioning

confidence: 99%

“…After screening, 135 patients were determined to meet all eligibility criteria and were treated with MR-guided focused ultrasound surgery at Brigham and Women's Hospital. The eligibility criteria for enrollment in the trial of MR-guided focused ultrasound surgery have been previously described (1)(2)(3)(4)(5). Patients with calcified fibroids were excluded.…”

Section: Patientsmentioning

confidence: 99%

Uterine Leiomyomas: MR Imaging–guided Focused Ultrasound Surgery—Imaging Predictors of Success

Lénárd¹,

McDannold²,

Fennessy³

et al. 2008

Radiology

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154

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Purpose:To retrospectively assess the magnetic resonance (MR) imaging predictors of success at reducing uterine leiomyoma volume and achieving patient symptom relief 12 months after MR imaging-guided focused ultrasound surgery. Materials and Methods:This single-center retrospective analysis of 71 symptomatic fibroids in 66 women was approved by the institutional review board and was HIPAA-compliant. Patients were treated with MR imaging-guided focused ultrasound surgery. The volume of treated fibroid and nonperfused volume (NPV) were calculated with software, while symptom outcome was assessed with a symptom severity score (SSS). Fibroids were classified as hyperintense or hypointense relative to skeletal muscle on pretreatment T2-weighted MR images. Results:Baseline volume of treated fibroids was 255.5 cm 3 Ϯ 201.7 (standard deviation), and baseline SSS was 61.5 Ϯ 14.9. Both pretreatment fibroid signal intensity (SI) and posttreatment NPV predicted 12-month volume reduction independently: Fibroids with an NPV of at least 20% or with low SI both showed significantly larger volume reduction (17.0% Ϯ 13.0 and 17.2% Ϯ 20.1, respectively) than fibroids with an NPV less than 20% or with high SI (10.7% Ϯ 18.2 and no significant change, respectively). Patients whose fibroids demonstrated an NPV of at least 20% also experienced a larger decrease in SSS than did patients with fibroids with an NPV less than 20% (50.1% Ϯ 19.8 vs 32.6% Ϯ 29.9). Conclusion:Fibroids with low SI on pretreatment T2-weighted MR images were more likely to shrink than were ones with high SI. The larger the NPV immediately after treatment, the greater the volume reduction and symptom relief were. These findings may help both in selecting appropriate patients for MR-guided focused ultrasound surgery and in predicting patient outcome.

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“…Later these thermal images were used to generate maps of the thermal dose (14) that could then be used to tailor the energy deposition using closed-loop feedback control (15). This preclinical work led to the development of the first commercial system by InSightec (Haifa, Israel), the Exablate 2000, the first implementation of a fully integrated MRgFUS system that combined a phased array transducer, a computer-controlled robotic positioner, and a workstation that integrated control based on MR thermometry.The early limited clinical trials of breast tumor treatment (8 -10,16,17) were followed by the first major clinical application: the noninvasive therapy of benign uterine fibroids (18,19). The successful Phase I trial was followed by a multicenter .…”

mentioning

confidence: 99%

“…The early limited clinical trials of breast tumor treatment (8 -10,16,17) were followed by the first major clinical application: the noninvasive therapy of benign uterine fibroids (18,19). The successful Phase I trial was followed by a multicenter Phase II trial (20 -22).…”

mentioning

confidence: 99%

Current status and future potential of MRI‐guided focused ultrasound surgery

Jólesz

McDannold

2008

Magnetic Resonance Imaging

112

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The combination of the imaging abilities of magnetic resonance imaging (MRI) with the ability to delivery energy to targets deep in the body noninvasively with focused ultrasound presents a disruptive technology with the potential to significantly affect healthcare. MRI offers precise targeting, visualization, and quantification of temperature changes and the ability to immediately evaluate the treatment. By exploiting different mechanisms, focused ultrasound offers a range of therapies, ranging from thermal ablation to targeted drug delivery. This article reviews recent preclinical and tests clinical of this technology. WHILE ITS POTENTIAL has been recognized for decades (1-4), focused ultrasound (FUS) therapy has been in the incubation phase for a long time. Although it has been tested in numerous animal experiments, its widespread clinical realization has lagged, primarily due to the lack of intraprocedural accurate temperature monitoring. When the idea of MRI-guidance was introduced in connection with FUS and MRI thermometry during sonication was demonstrated (5,6), it was anticipated that MR-guided FUS surgery (MRgFUS) would be widely accepted clinically within a few years. Despite these early expectations, there has been relatively slow progress in the clinical implementation of MRgFUS.Early development concentrated primarily on breast tumors (benign fibroadenoma (7,8) and malignant breast cancer (9,10)). These early implementations of the MRgFUS technology motivated the improvement of transducer technology from single-element transducers to MRI-compatible multielement phase arrays (11). There was also significant progress in MRI thermometry and its use to monitor and control sonications. Importantly, too, methods were developed to robustly quantify temperature changes (12). At first, only 2D temperature maps were obtained by MRI to allow for accurate targeting of the beam (13). Later these thermal images were used to generate maps of the thermal dose (14) that could then be used to tailor the energy deposition using closed-loop feedback control (15). This preclinical work led to the development of the first commercial system by InSightec (Haifa, Israel), the Exablate 2000, the first implementation of a fully integrated MRgFUS system that combined a phased array transducer, a computer-controlled robotic positioner, and a workstation that integrated control based on MR thermometry.The early limited clinical trials of breast tumor treatment (8 -10,16,17) were followed by the first major clinical application: the noninvasive therapy of benign uterine fibroids (18,19). The successful Phase I trial was followed by a multicenter . These clinical trials led to the approval of this technology for the treatment of uterine fibroids in several countries, including the United States. Examples of MR thermometry and postablation imaging of a uterine fibroid ablation are shown in Figure 1.The success of uterine fibroid ablation has invigorated the entire field. Technology has rapidly improved and clinical applications ke...

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Focused ultrasound treatment of uterine fibroid tumors: Safety and feasibility of a noninvasive thermoablative technique

Cited by 397 publications

References 17 publications

The safety and feasibility of extracorporeal high-intensity focused ultrasound (HIFU) for the treatment of liver and kidney tumours in a Western population

The safety and feasibility of extracorporeal high-intensity focused ultrasound (HIFU) for the treatment of liver and kidney tumours in a Western population

Uterine Leiomyomas: MR Imaging–guided Focused Ultrasound Surgery—Imaging Predictors of Success

Current status and future potential of MRI‐guided focused ultrasound surgery

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