Copy of Development of methods for characterising and testing clinical High Intensity Focused Ultrasound (HIFU) systems

Lead Research Organisation: Institute of Cancer Research
Department Name: Division of Radiotherapy and Imaging

Abstract

The clinical application of high intensity focused ultrasound (HIFU) to the treatment of soft tissue cancers of, for example, the liver, kidney and prostate, is a young and rapidly expanding field. To date more than 30,000 patients have been treated world wide. Successful treatment is achieved when the temperature of the tumour is raised to levels at which instantaneous cell death occurs. The focused beam ensures that only the tissue being targeted is heated, whilst surrounding tissue remains unharmed. Safe and effective use of HIFU requires that validated methods for measurement and testing of clinical devices should be made available as soon as possible. These issues have not been addressed to date in any systematic fashion. Clinical HIFU systems are currently assessed on an ad hoc basis by individual clinical departments and manufacturers, using methods, many of which are unpublished. There is, therefore, an urgent need to produce standard registration and testing equipment and methodology that allows users to characterize clinical HIFU systems for the purposes of checking safety and reproducibility of a machine's output, comparing different devices or commissioning new systems. The programme of work proposed is a mixture of adaptation and extension of existing and emerging techniques to meet the requirements of this new medical technology, and the development of novel methods specifically for this application.The overall aim of this project is to improve the efficacy, safety and range of applicability of clinical HIFU treatments by:A. providing validated methods for: * ultrasonic field characterisation using pressure field mapping and acoustic power measurement techniques; * HIFU system performance testing and quality assurance using novel thermal and cavitation mapping methods * patient exposure monitoring by means of electrical impedance measurements and real time acoustic power measurement;B. establishing a world leading HIFU characterisation facility at the Institute of Cancer Research (ICR);C. disseminating the successful methods, protocols and equipment to a wider user base through: * scientific publication; * contribution to written National and International Standards; * commercial exploitation.

Publications

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Civale J (2011) Measurement of Angle of Ultrasound Propagation from Phase in Journal of Physics: Conference Series

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Gail Ter Haar (Author) (2007) Medical Ultrasound ? Is it safe? in Health Protection Matters

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Kaiplavil S (2013) Ultrasound imparted air-recoil resonance (UIAR) method for acoustic power estimation: theory and experiment. in IEEE transactions on ultrasonics, ferroelectrics, and frequency control

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Mouratidis PXE (2019) 'Relationship between thermal dose and cell death for "rapid" ablative and "slow" hyperthermic heating'. in International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group

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Shaw A (2015) Towards a dosimetric framework for therapeutic ultrasound. in International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group

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Shaw A (2016) Equipment, measurement and dose-a survey for therapeutic ultrasound. in Journal of therapeutic ultrasound

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Ter Haar G (2011) Guidance on reporting ultrasound exposure conditions for bio-effects studies. in Ultrasound in medicine & biology

 
Description We have developed and set up a world leading HIFU quality assurance facility at the Institute of Cancer Research / Royal Marsden Hospital Trust
Exploitation Route We have collaborated with a French group by calibrating some of their transducers in order that the data can be compared to their in-house calibration.

Publication of our developments allows others to implement best practice including those informing standardisation committees.
Sectors Education,Healthcare

 
Description European Union EU Brussels
Amount £1,668,000 (GBP)
Funding ID EMRP project HLT-03 - therapeutic ultrasound 
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 04/2013 
End 04/2015
 
Description FUSF Centre of Excellence funding
Amount $450,000 (USD)
Organisation Focused Ultrasound Foundation 
Sector Charity/Non Profit
Country United States
Start 01/2014 
End 12/2016
 
Description Focused Ultrasound Foundation's Centres of Excellence
Amount $450,000 (USD)
Organisation Focused Ultrasound Foundation 
Sector Charity/Non Profit
Country United States
Start 01/2014 
End 12/2016
 
Description Euramet collaboration 
Organisation National Physical Laboratory
Country United Kingdom 
Sector Academic/University 
PI Contribution Thermal dose studies were undertaken at the ICR and NPL with ICR leading the biology and physics and NPL leading the metrology
Collaborator Contribution NPL provided consultancy, equipment and access to facilities at NPL
Impact Publications
Start Year 2013
 
Description NPL 
Organisation National Physical Laboratory
Country United Kingdom 
Sector Academic/University 
PI Contribution We carried out the major part of this project, developing measurement methods
Collaborator Contribution NPL contributed advice and expertise to help develop measurement methods
Impact Papers, conference presentations
Start Year 2007
 
Description Philips 
Organisation Philips Healthcare
Country Netherlands 
Sector Private 
PI Contribution Working with Philips on HIFU research, and to test their Sonalleve HIFU system in the clinic.
Collaborator Contribution Philips have provided the Sonalleve system, and sponsored the clinical trial. They are also funding a PhD student
Impact Collaboration is multi-disciplinary, involving Physics, engineering & clinical medicine
Start Year 2013