Biomedical Engineering Reference
In-Depth Information
10
Clinical External Ultrasonic
Treatment Devices
Lili Chen
Fox Chase Cancer Center
10.1 Introduction .............................................................................................................................177
10.2 InSightec Systems ....................................................................................................................177
ExAblate 2000/ExAblate
•
One • ExAblate 2100/ExAblate
•
OR • ExAblate 4000 (ExAblate
Neuro Transcranial [tc]) MRgFUS System
10.3 Haifu Systems ...........................................................................................................................181
Main Components • US Imaging Guidance • Quality Assurance • Treatment
Planning • Treatment Dose Delivery
10.4 Philips Sonavelle MR-HIFU System .....................................................................................186
References .............................................................................................................................................187
Faqi Li
Chongqing Medical University
Feng Wu
Chongqing Medical University
and University of Oxford
Eduardo G. Moros
H. Lee Moffitt Cancer Center
and Research Institute
10.1 Introduction
cancer. MRgFUS is also being investigated for the treatment of
liver tumors, stroke, epilepsy, movement disorders, and pan-
creatic and kidney tumors. Ultrasound guided FUS is currently
being used clinically in the treatment of kidney, liver, and pan-
creatic cancers in several countries (Wu et al. 2004, Ritchie et al.
2010, Zhang et al. 2010). Several manufacturers are currently in
the process of developing commercial clinical FUS systems. This
chapter focuses on the introduction of clinical externally applied
ultrasound devices that have been approved by the Food and
Drug Administration (FDA) in the United States and/or have
the
Conformité Européenne
(CE) mark of approval for clinical
application, which consist of the ExAblate system (
I n S i g ht e c-Tx-
Sonics, Haifa, Israel, and Dallas, Texas
) with MR guidance and
the Haifu system (Chongqing Haifu [HIFU] Technology Co.,
Ltd, China) with ultrasound guidance. The Philips Sonavelle
MR-HIFU system that is expected to be the next clinical system
to be cleared by the FDA/CE is also presented briefly.
High intensity focused ultrasound (HIFU) or focused ultra-
sound surgery (FUS) is a completely noninvasive treatment
modality. It has long been known to offer “trackless lesioning,”
and it has been identified as an “ideal surgical tool” for several
decades. However, only after it was integrated with modern
imaging methods has HIFU become a clinical reality. A high
quality imaging technique was needed to provide visualization
and localization of target tissue, monitoring of tissue changes
during treatment, and outcome assessment after treatment.
FUS integrated with a modern imaging system has been used
for treating both benign and malignant diseases, such as uter-
ine fibroids, benign prostatic hyperplasia, prostate cancer, breast
cancer, brain tumors, and palliative treatment of bone metas-
tases to relieve pain (Gianfelice et al. 2008, Funaki et al. 2009,
Furusawa et al. 2006, 2007, Liberman et al. 2009, McDannold
et al. 2010, Zhang and Wang 2010). Its future potential is vast
both in surgical and other interventions. For example, pulsed
mode FUS has recently been used to enhance local drug deliv-
ery in animal models (Yuh et al. 2005, Rapoport et al. 2009,
Nelson et al. 2002, Khaibullina et al. 2008, Chen et al. 2010).
The imaging modalities that have been integrated for treatment
guidance include both ultrasound (US) imaging and magnetic
resonance (MR) imaging. The advantages and disadvantages of
each imaging modality are discussed elsewhere in this topic.
MR guided focused ultrasound surgery (MRgFUS) has been
used clinically for the treatment of uterine fibroids and is being
studied in clinical trials for the treatment of patients with bone
metastases, breast tumors, and brain tumors, as well as prostate
10.2 InSightec Systems
10.2.1 Exablate 2000/Exablate
®
One
The ExAblate 2000 provides noninvasive surgery using MR
guidance. It is mainly designed for treating uterine fibroids
and bone metastases, but can also be used for treating other
sites such as breast cancer, liver cancer, and pancreatic cancer.
Moreover, recent reports demonstrate that the system can also
be used for small animal research studies on the enhancement
of local drug delivery using pulsed focused ultrasound (Chen et
al. 2010, Mu et al. 2012).
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