Diagnostic and Interventional Imaging (2014) 95, 339—343

TECHNICAL NOTE / Oncology

Magnetic resonance guided focalised ultrasound thermo-ablation: A promising oncologic local therapy A. Iannessi a,∗, J. Doyen b, A. Leysalle b, A. Thyss c a

Service de radiologie diagnostique et interventionnelle, Bat A, Centre de lutte contre le cancer Antoine-Lacassagne, 33, avenue de Valombrose, 06189 Nice cedex 2, France b Service de radiothérapie, Bat B, Centre de lutte contre le cancer, Antoine-Lacassagne, 33, avenue de Valombrose, 06189 Nice cedex 2, France c Unité de soins continu en hématologie, Bat B, Centre de lutte contre le cancer, Antoine-Lacassagne, 33, avenue de Valombrose, 06189 Nice cedex 2, France

KEYWORDS High-intensity focused ultrasound; Functional MRI; Thermo-ablation; Bone pain; Non-invasive

Pain management of bone metastases is usually made using systemic and local therapy. Even though radiations are nowadays the gold standard for painful metastases, innovations regarding minimally invasive treatment approaches have been developed because of the existing non-responder patients [1]. Indeed, cementoplasty and thermo-ablations like radiofrequency or cryotherapy have shown to be efficient on pain [2—4]. Among thermotherapy, magnetic resonance guided focalised ultrasound is now a new non-invasive weapon for bone pain palliation.

Discussion Magnetic resonance image-guided focused ultrasound surgery (MRgFUS, ExAblate, InSightec, Tirat Carmel, Israel) is an innovative technology combining two distinct approaches: high-intensity focused ultrasound (HIFU) and a magnetic resonance imaging system (MRI) [5]. HIFU is a well-known technique, which has been first introduced for biological ablation in 1942 [6]. It allows destroying targeted tissue not invasively by increasing the temperature locally. What is new about it is the MRI guidance and monitoring. Indeed, functional and morphologic sequences provide both accurate localisation targeted tumours and temperature monitoring [7—9].



Corresponding author. E-mail address: [email protected] (A. Iannessi).

2211-5684/$ — see front matter © 2013 Éditions françaises de radiologie. Published by Elsevier Masson SAS. All rights reserved. http://dx.doi.org/10.1016/j.diii.2013.09.003

340 The device is made of a modified table compatible with the existing MRI platform and a workstation to control the system (Fig. 1). Focused ultrasound waves are generated from a phased array transducer with 256 elements. The waves are focused for 15 to 25 seconds to yield heat on an ellipsoid-shaped spot measuring up to 7 cm. Each ultrasound energy deposition is called ‘‘sonication’’. The energy delivered by a single shoot is sufficient to increase tissue temperature above the denaturing proteins thermal dose threshold. It results in a coagulative necrosis [10]. The operator desktop station allows both the MRI and the HIFU system control. After calibration, the first step is the definition of the treatment zone. T2-weighted images are used by the physician to define the tumor target. Moreover, the fusion with CT scan can be helpful. Then, to ensure that the entire volume receives adequate thermal dose, the software proposes a three dimension treatment plan composed of multiple sonications [10,11]. However, the operator can change the shape, size, intensity of the acoustic beams to tailor the treatment ‘‘in real time’’ and protect surrounding organs at risk [12,13]. On the screen, feedback to predict efficiency of the sonication is available through ultrasound propagation monitoring and in vivo magnetic resonance thermal map (Fig. 2) [14]. In addition, after the procedure, a post-contrast sequence offers an estimation of the ablated tissue which turns out to be non-perfused. Also, functional MRI sequences could improve residual tumour estimation after treatment using perfusion MR or diffusion weighted imaging.

A. Iannessi et al. For bones, the targeted ablation aims at denervating the periostium invaded by the tumour and yielding pain relief. In this case, the focus point is placed behind the targeted bone to allow a larger field of heating (Fig. 2). This is made possible because bone absorbs about 50 times as much ultrasound energy as soft tissues [15]. Typical bone procedure lasts 2 hours, including approximately 1 h of sonication time. As the periosteal ablation is painful, the anaesthesia management is a key factor to maintain the patient’s comfort, avoids movements during the procedure, and allows the physician to reach adequate levels of energy. Two options are possible: first, a locoregional anaesthesia like nerve block or spinal; second, the combination of a deep sedation and a local anaesthesia (usually performed under x-ray guidance). MRgFUS device is approved by Food and Drug Administration (FDA) and the European Community (CE) for the treatment of uterine fibroma and painful bone metastases and is currently under evaluation for the treatment of solid tumours in the brain, breast, prostate, liver and pancreas [16—19]. Others devices are available but only two are guided by MRI. Each system needs to be marked for a specific indication; we have summarised the existing devices in Table 1. Among different studies, all patients have reported fast (< 48 h) and significant pain reduction (Visual score drop > 2 points) in treated bones and a drop in the use of painkillers [19,20]. No adverse events have been recorded. These results are very promising and a larger multicenter study for bone palliation using the MRgFUS approach is being conducted to compare it with radiation. The real challenge

Figure 1. Painful rib metastasis treated by MRgFUS, hardware device and patient positioning. A 54-year-old patient with lung cancer has left thoracic pain (numerical scale = 6/10). A whole body PET-CT has been performed and showed a left rib lesion. Before treatment, an axial T2-weighted MR is performed to be sure that the targeted rib lesion is visible (empty arrow). During the treatment, a local anaesthesia performed on the periosteum (hypersignal T2) allows pain control (plain arrow). As the transducer (red prism) is inside the MRI table, the patient has to be installed in ventral decubitus position to expose the target toward the ultrasound beam. The skin must be directly in contact with the gel pad and the water bath (star) to avoid air interface (risk of skin burn). The system needs a cooler system connected to a water source (plain arrowhead).

Magnetic resonance guided focalised ultrasound thermo-ablation

341

Figure 2. Painful rib metastasis treated by MRgFUS, during the treatment. Same patient in Fig. 1. The system allows both control and verification during the procedure. The thermal map sequence is repeated each 4 seconds for 30 seconds (empty arrowhead). The morphologic T2-weighted images are required to detect movements (plain cross). For bone, the cortical surface (green line) is the target of the lesion and beam focalisation is voluntary planned behind it. The yellow circle represents the area of heating for one sonication. All parameters are accessible and can be modified (empty star). The sonication time is 20 seconds and the thermal curve shows the correct increase and decrease of the temperature (empty cross). After treatment, the patient was completely relieved within 48 hours and the pain relief is still lasting 6 months after the procedure.

for oncology is to treat malignant lesions with a curative endpoint as an alternative to surgical resection. We think that the best research fields are expected for localised cancer, precancerous lesions or as a second option after an initial surgery [21,22]. Curative approach has been

Table 1 High intensity focalised ultrasound devices available for medical use. Company

Commercial name

Guidance

InSightec, Haifa, Israel

ExAblate 2000 ExAblate 4000 Sonalleve MR-HIFU

MR

Haifu Sonablate 500 Ablatherm HIFU TH-One

US

Philips Healthcare, Netherlands Chongqing Haifu, China Misonix, US EDAP, France Theraclion, France

evaluated for breast cancer by some promising studies and requires a larger study with a perfect design (i.e. confirmation lumpectomy) [23—26]. Actually, thanks to new higher energy and multi-element transducers experimental brain applications are very promising without craniotomy [27,28]. In fact, FDA approval has been obtained for treatment of essential tremor. Prostate is commonly treated with surgery, radiotherapy, cryotherapy and HIFU guided by ultrasound. Specific intrarectal transducers are available to treat prostatic cancer [29,30]. Abdomen applications are being investigated to solve movement problems [31—36]. The pros and cons of MR guided ultrasound thermoablation compared to other local approaches such as surgery and radiotherapy are shown in Table 2. For curative project, non-invasive approach is usually a second line therapy due to the absence of pathological confirmation. However, a treatment combining ultrasound thermo-ablation for the targeted macroscopic solid tumours with radiotherapy for sub-microscopic sterilization might be a future strategy to consider [37].

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Table 2

Advantages and disadvantages of local treatments for cancer.

MRgFUS

Surgery

Radiation

Invasive technique = Lancet higher morbidity risk (blood loss)

Non invasive = ionizing radiation

Deep sedation or general anaesthesia

Not required

Macroscopic and microscopic disease: pathological confirmation (enables chemotherapy adaptation) Submicroscopic disease: undetectable

Macroscopic and microscopic disease: not evaluable

Single procedure Long procedure Follow-up hospitalization

Multiple procedure Short procedure No hospitalization

Resectability Patient comorbidity

Dose limitation Radio-induced cancer

Destroying medium Non invasive = Heat Anaesthesia Local or deep sedation Initial evaluation (completeness of treatment) Macroscopic disease: gadolinium MRI, functionnal MRI (DWI-Perfusion) Microscopic and submicroscopic disease: undetectable Time and cost evaluation Single procedure Short procedure Short hospitalization MRI required Treatment limitations Ultrasound penetration limitation

Conclusion MR guided ultrasound thermo-ablation is a promising noninvasive technique offering new opportunities for the treatment of cancer patients. However, its efficacy in the treatment of solid cancer has still to be proved by larger trials alone or combined with surgery or radiations.

Disclosure of interest Dr. Iannessi is investigator for an international multicenter study whose promoter is InSightec company: étude de phase IV visant à comparer l’innocuité et l’efficacité des ultrasons focalises guides par résonance magnétique et celles de la radiothérapie externe dans le cadre du traitement des tumeurs osseuses metastatiques et de myelomes multiples douloureuses. Référence CCP: 12.061. Others authors declare no potential conflict of interest.

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Magnetic resonance guided focalised ultrasound thermo-ablation: a promising oncologic local therapy.

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