Study in British Journal of Urology International Features a Practical Solution for MRI-Ultrasound Fusion to Enable Tumor-Targeted, Tissue-Preserving Prostate HIFU Treatment

CHARLOTTE, N.C. and LONDON, July 25, 2013 /PRNewswire/ -- Study results published in the current issue of British Journal of Urology International (10.1111/bju.12223) demonstrate that new software to register and fuse information from magnetic resonance imaging (MRI) and ultrasound (US) images enables intraoperative visualization of tumors, not ordinarily seen in a US image. This technology has the potential to support new tissue-preserving treatments for prostate cancer, such as focal therapy.

In the study, "Image-Directed, Tissue-Preserving Focal Therapy of Prostate Cancer: a Feasibility Study of a Novel Deformable MR-US Registration System" researchers from University College London (UCL) evaluated the feasibility of using a computer-assisted, deformable image registration software to enable three-dimensional, multi-parametric MRI derived information on tumor location and extent to inform both the planning and treatment phase of focal high intensity focused ultrasound (HIFU) therapy using SonaCare Medical's Sonablate® 500 system.

Nested within the multi-center INDEX Trial, this pilot study employed computer assisted MRI-US image registration software within the planning of the first 26 men with a MRI-visible tumor treated at UCL with HIFU using a tissue-preserving quadrant, hemispheric (hemi) or extended hemi ablation therapy. Results demonstrated that the software, developed at UCL, enables information of tumor location to be used for therapy planning using the Sonablate® 500 system without adding significant extra time to the standard procedural workflow. Such planning is particularly important for new tissue-preserving treatment approaches to ensure that the tumor is completely treated.

"Multi-parametric MRI has shown promise as an accurate method for determining the focality of tumors, and has promise as a potentially important enabler for minimally-invasive, tissue-preserving, or focal, HIFU treatments.  However, most ablative technologies for localized prostate cancer use an ultrasound platform to plan and deliver treatment, on which the tumor cannot be accurately localized. This often results in discrepancies between the tumor and target volumes, potentially leading to under-treatment at the margins, or treatment of larger tissue volumes to compensate for inaccuracies in targeting," said lead author Louise Dickinson of UCL. "We are very pleased that the results of this pilot study demonstrate that deformable image registration is feasible and safe when introduced into a HIFU ablative therapy setting and suggests potential for improving the accuracy of targeting lesions using a tissue-preserving focal therapy approach."

The research is based on breakthrough image analysis algorithms developed at the UCL Centre for Medical Image Computing and has undergone extensive clinical evaluation as part of clinical research studies led by Professor Mark Emberton, MD, Professor of Interventional Oncology and Director of the Division of Surgery and Interventional Science at UCL. Twenty-six prostate cancer patients have been successfully treated at UCLH using the Sonablate^® 500 with the aid of this software as part of the INDEX Trial.

Dr. Dickinson added: "Indeed, if on-going clinical trials demonstrate clinical utility for focal therapy as an alternative to current standards of care, it is possible that image registration software may be essential for the efficient implementation of truly focal therapy techniques in which individual tumors are treated within an appropriate and safe surgical margin. The use of MRI-US registration potentially provides a cost-effective solution that, as shown in this study, can be easily integrated within existing workflows and interfaces, using standard surgical equipment."

Subsequent to this research, the team at UCL, led by Dr. Dean Barratt, is now developing a commercial version of their prostate image registration/fusion software, called "SmartTarget", with funding from the UK Department of Health and Wellcome Trust Health Innovation Challenge Fund. The SmartTarget project focuses on translating technology, which combines state-of-the-art diagnostic imaging with advanced image guidance technology to provide doctors with information on cancer location, size and shape so that it can be used to direct and guide prostate biopsy and minimally-invasive cancer treatments. In particular, the SmartTarget system exploits MRI, which can detect and characterize clinically significant cancers in a large proportion of patients.

Recently SonaCare Medical, a global leader in minimally-invasive High-Intensity Focused Ultrasound (HIFU) technologies, and UCL Business PLC (UCLB), a leading technology transfer company that supports and commercializes research and innovations from UCL, announced a partnership to integrate SmartTarget image registration and fusion software into SonaCare Medical's innovative Sonablate® 500 HIFU system.

"The adoption of tissue preserving approaches for the treatment of prostate cancer has been hampered by limitations in diagnosing and localizing clinically significant prostate cancers," said Mark Carol, M.D., Chief Development Officer for SonaCare Medical.  "The publication of these results in the British Journal of Urology International is a tremendous validation of UCL's pioneering research in image registration and fusion technology that has led to significant advances in the validation and adoption of focal HIFU.  We are proud to work with UCL to expand access to this breakthrough technology designed to enable targeted treatment of clinically significant prostate cancers."  

About UCL (University College London)
Founded in 1826, University College London (UCL) was the first English university established after Oxford and Cambridge, the first to admit students regardless of race, class, religion or gender, and the first to provide systematic teaching of law, architecture and medicine. We are among the world's top universities, as reflected by performance in a range of international rankings and tables. UCL currently has 24,000 students from almost 140 countries, and more than 9,500 employees. Our annual income is over £800 million. www.ucl.ac.uk

About UCL Business PLC
UCL Business PLC (UCLB) is a leading technology transfer company that supports and commercialises research and innovations arising from UCL, one of the UK's top research-led universities. UCLB has a successful track record and a strong reputation for identifying and protecting promising new technologies and innovations from UCL academics. UCLB has a strong track record in commercialising medical technologies and provides technology transfer services to UCL's associated hospitals; University College London Hospitals, Moorfields Eye Hospital, Great Ormond Street Hospital for Children and the Royal Free London Hospital. It invests directly in development projects to maximise the potential of the research and manages the commercialisation process of technologies from laboratory to market.

UCLB supports UCL's Grand Challenges of increasing UCL's positive impact on and contribution to Global Health, Sustainable Cities, Intercultural Interaction and Human Wellbeing. www.uclb.com

About the Health Innovation Challenge Fund
The Health Innovation Challenge Fund is a parallel funding partnership between the Wellcome Trust and the Department of Health to stimulate the creation of innovative healthcare products, technologies and interventions and to facilitate their development for the benefit of patients in the NHS and beyond. www.hicfund.org.uk

About the Wellcome Trust
The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust's breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests. www.wellcome.ac.uk

About the Department of Health
The Department of Health works to improve the health and well-being of people in England. The Department sets overall policy on all health issues and is responsible for the provision of health services through the National Health Service. www.dh.gov.uk 

About SonaCare Medical
SonaCare Medical, a privately held, venture-backed healthcare company is a world leader in minimally-invasive high intensity focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing technologies for urological indications that offer precise and innovative procedures that can control cancer and reduce potential quality of life altering side effects. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures high intensity focused ultrasound (HIFU) medical devices, including the following: Sonablate^® 450 which is investigational in the U.S. and being studied in a pivotal FDA clinical trial as a possible treatment for recurrent prostate cancer in patients treated previously with external beam radiation therapy; Sonablate^® 500 which has CE Marking and is, or has been, approved for use to treat prostate cancer in more than 30 countries outside the U.S.; and Sonatherm^® laparoscopic HIFU surgical ablation system which is 510(k) cleared in the U.S. The FDA has made no decision as to the safety or efficacy of Sonablate^® 450 or 500. In the event Sonablate^® 450 is approved by the FDA for use in the U.S., there is no assurance that instructions for use or the specifications of the device will be the same for treatment approved or authorized in other countries outside of the U.S.

SonaCare Medical was founded in 2004 and is headquartered in Charlotte, N.C. www.SonaCareMedical.com

SOURCE SonaCare Medical