Project: Development of an MR-guided Focused Ultrasound device for the treatment of Prostate cancer (PROFUS)

The objective of the PROFUS project is to develop and to clinically evaluate an innovative device for treating prostate cancer using High Intensity Focused Ultrasounds (HIFU or FUS) under guidance and control of Magnetic Resonance (MR) imaging. The new device will provide a treatment that is non-invasive, safer, more effective and reliable than the current state of the art procedures._x000D_In Europe, prostate cancer is the most common cancer form for men; around 323 000 new cases of prostate cancer are diagnosed in Europe each year [GLOBOCAN 2008, IARC]. Prostate cancer is the second leading cause of cancer death in males in Europe (12%)._x000D_Over the last decade, prostate cancer treatment has evolved toward less invasive procedures. Open surgery for radical prostatectomy, for instance, is progressively being replaced with robotic surgery (86% of interventions in the US are performed with a Da Vinci robotic surgery system, cf. Intuitive Surgical). New techniques, based on thermal ablation, introduce an even greater paradigm shift in term of treatment than robotic surgery. Among those techniques, High Intensity Focused Ultrasound (HIFU or FUS) stands prominently because it is totally non invasive. The principle of HIFU is based on the concentration of high intensity ultrasound beams into a very small focal spot where the temperature rises rapidly above a lethal threshold causing the destruction cancerous tissue. HIFU is considered as a very promising thermal ablation technique and has proved effective in destroying localized cancers in organs such as prostate, breast and bone. There are currently only two CE marked HIFU devices for the prostate: the Sonablate 500 (Focus Surgery) and the Ablatherm (EDAP)._x000D_However, in their current implementation, HIFU devices for treating prostate cancer present several important limitations such as:_x000D_1. the impossibility to control effectively the treatment while it is performed and to adjust the protocol in real time based on actually measured temperatures. Indeed, image guidance is currently performed by transrectal ultrasonography (TRUS) which provides only qualitative information about the ongoing treatment. This leads both to safety issues and to a reduced efficacy since some parts of the tumor are over-treated and some may be left untreated. _x000D_2. the impossibility to adjust the focal spot position. Current commercial HIFU devices for prostate treatment have a fixed focus. This means that tissues destruction away from the transducer is achieved by heat diffusion only and not by adjusting the position of the focal spot. This process can lead to ill-defined ablation at the periphery and overheating at the focus._x000D_3. the sequential destruction of small sub-volumes of the tumor. A better approach would consist in a volumetric destruction of the target region by a homogeneous heating._x000D_4. the absence of motion detection of the targeted organ during the treatment. If organ motion occurs during treatment, the overlap of small, FUS induced lesions is not perfect and residual living tumor cells reCO leading to cancer recurrence._x000D_Two competing projects are also currently underway to provide improvements to the current HIFU technology. One is led by Insightec, a US-Israeli company which has started a phase I trials with a new MR guided trans-rectal HIFU system. The second is led by Profound Medical, a Canadian company which develops an MR-guided trans-urethral system for prostate cancer treatment._x000D_The PROFUS consortium intends to develop an MR-guided HIFU system for the treatment of prostate cancer that not only overcome the limitations of the current devices (Focus Surgery, EDAP), but also improve on the technology currently being developed elsewhere (Insightec, Profound Medical)._x000D_PROFUS objective is not to couple an existing HIFU technology with a different imaging modality, MR imaging (which in itself is not a trivial development), but rather to develop a new system, from first principles, based on the requirements of patient safety, clinical efficacy, treatment reliability and cost effectiveness._x000D__x000D_The project will be implemented by an international consortium composed of 5 industrial and academic Ps with specific and very complementary expertise in order to cover all the topics of the project:_x000D_IMAGE GUIDED THERAPY (IGT), design of MR compatible phased array transducer and driving electronics, and real time treatment control._x000D_German Cancer Research Centre (DKFZ): MR pulse sequence development, RF coil development and interventionnal MR_x000D_MEDIRI: MR imaging, medical image processing, software development and quality assurance protocol design._x000D_RADBOUD UNIVERSITY HOSPITAL OF NIJMEGEN (RUNMC) : treatment of prostate cancers and in multi-parametric MR-protocol development._x000D_MEDSONIC: MR compatible robotic positioning systems and MR guided HIFU.

Acronym PROFUS (Reference Number: 6620)
Duration 22/11/2011 - 31/10/2015
Project Topic The objective of PROFUS is to develop and evaluate clinically an innovative medical device, using focused ultrasound under MR imaging control, to provide an alternative, non invasive method to treat prostate cancer effectively and reliably without the complications of surgery.
Project Results
(after finalisation)
_x000D_We have developed the controlling software that moves the positioning device (movement of the motors with feedback control using MRI compatible encoders). The program was written initially in MATLAB. Because MATLAB is slow, for the motor control we finally use the programming language of C. The accuracy of the positioning device was greatly improved. _x000D__x000D_We have developed the driving electronics enclosure of the positioning device. The positioning device includes a 24 V DC supply and thus direct connection to a 240 V AC supply is now possible. The enclosure is completely ready for commercialization. We have developed subprograms for the control of the encoder which is MR compatible. _x000D_
Network Eurostars
Call Eurostars Cut-Off 6

Project partner

Number Name Role Country
5 Radboud University Nijmegen Medical Centre Partner Netherlands
5 University Clinic of Freiburg Partner Germany
5 MEDSONIC Partner Cyprus
5 MEDIRI GmbH Partner Germany
5 Image Guided Therapy SA Coordinator France