BERLIN, GERMANY (Press Release) - EAU 2007 - "Ablatherm: an elegant solution for patients who are not suitable for surgery" Dr Albert Gelet

Interview carried out as part of European Prostate Cancer Day,
Organised by the member of the Association Francaise d'Urologie (AFU), the French Urology Association on 15th September 2006, Hopital Edouard Herriot (Pavilion V Urology).

A HISTORICAL OVERVIEW
"In the beginning, the idea was that if we could break up kidney stones, well, we should be able to break up tumours!"tells Dr Albert Gelet.

The history of ultrasounds is an old one:
• Pierre and Jacques Curie discover Piezoelectricity at the start of the 20th century
• A few years later, Paul Langevin invented the "triplet", an ingenious system which enables an ultrasound beam to be emitted. Originally intended to be used by the Army to find submarines, the heat it emitted let people think that medical application might be possible.
• The idea to make ultrasounds converge at a single point to destroy tissue was born after the Second World War; a great many experiments were carried out by the FRY brothers in the 1960s in the United States.
• The first model considered was the one for Parkinson's disease, with the objective of destroying tissue deep down.

"The ultrasound enabled us to cause lesions in the brain" said Dr A Gelet "but the project could not succeed as at the time the FRY brothers didn't have ultrasound, IT or a scanner, in short they had nothing to guide the ultrasound!" The arrival of anti-Parkinson medicines spelt the end for the technique and stereotaxy. "Thanks to progress in electronics and IT, we have been able to pick up the principle of focused ultrasound" continued Dr A Gelet.

AN INDUSTRIAL MEDICAL-SCIENTIFIC ENCOUNTER
Thanks to the synergy between a doctor (Dr Albert Gelet HEH Lyons), a scientist (Dr Jean-Yves Chapel on, Inserm U556, Lyons) and an engineer (Emmanuel Blanc, EDAP), the Ablatherm project was born from the desire to design a machine which was able to destroy tissue irreversibly thanks to the use of ultrasound. "The same type of synergy which was produced in 7987 between Professors Dubernard and Martin of the Urology department at HEG, the INSERM and EDAP" underlined Dr Gelet, ... and which had then led to the development of the lithotriter for which 350 models were sold worldwide at the time of Technomed! "Studies relating to the effects of ultrasound on animals began in 7 989" recalled Dr Gelet, the "the autorisation to treat patients was obtained in 7992 under the Huriet law which regulated experimentation on humans."

TECHNICAL 100M... A very fine development!

Globally, ultrasound may be used with different intensities:
• High intensity for a short period (a few milliseconds) which leads to an explosion of the tissues by a cavitation phenomenon due to the formation and vibration of intra-tissue micro-bubbles.
• A more moderate intensity for a longer period (several seconds) which translates into a thermal effect due to the absorption of energy at the focal point, like the sun's rays concentrated through a magnifying glass.

"This is the double effect created by the Ablatherm lesion" explained Dr Gelet. The thermal accumulation is effectively such that the energy released provokes a caviation effect. But this phenomenon, which was described as random - Rayleigh, Nobel Prize in 1904-, is found in the new inspection system, and is produced continuously.

FROM EMPIRICISM TO THE MATHEMATICAL MODEL
"At the beginning, everything was done by trial and error, and this empiricism continued until 2000" revealed Dr. Gelet ... but things became much more refined, until the equation of Ablatherm by Dr Jean-Yves Chapelon and Francoise Chavrier, a researcher at the INSERM. "There is now a very complex mathematical model which enables us to predict what will happen in human tissue and because we have a machine which calculates the destruction area this has greatly simplified the task for the user!" Dr Gelet said happily.

A POINT BY POINT DEMONSTRATION
After the princeps step which proved the irreversibility of the tissue lesions, we then had to show that the destruction of the cancerous tissue was effective and that there was no risk of metastases, The demonstration was carried out on experimental tumour modules implanted in rats in 1992 and 1993.

ZOOM: Two models were used for the demonstration:
• A Dunning line experimental animal tumour in which 10 mg of cancerous tissue was grafted under the skin of the Copenhagen rat causing the death of the animal within 3 weeks with no HIFU treatment.
• A model in which a human tumour was grafted onto a bare mouse also leading to death within 3 weeks.

  Conclusion of step No.2:
  From 1992 we had a system which enabled us to cure rats with tumours thanks to focused ultrasound without causing any metastases, "The next step was to show that we could send focused ultrasound in dogs able to cross the rectum and reach the prostate" recounted Dr Gelet given that at the time they were considering the creation of an extra-corporal machine adapted to treating the kidney or the liver. But the prostate "offered" a large number of localised cancers, identified using the PSA dosage, in patients for whom surgery was not desirable,

  Conclusion of step No.3:
  Mission accomplished in 1992!
  A LONG ROAD FOR THE BENEFIT OF HUMAN THERAPY
  "The first patient was able to be treated in February 7993 with an Ablatherm prototype, then around one hundred cases enabled us to refine the development, up to the marketing of a reliable machine in 2000" summarised Dr Gelet. In 1996 the prototype was duplicated in order to carry out a test phase in several hospitals in France and in Germany. "The European multi-centre test - carried out on 400 treated patients - enabled us to obtain CE marking for 'Ablatherm@ ... which gave us great satisfaction after seven years spent perfecting the machine!" recognised Dr Albert Gelet.

  PERPETUAL OPTIMISATION
  "We know how the machine works and we know its qualities and its limitations. Our responsibility therefore is to keep developing and advancing it" declared one of its three fathers, whose clinical commitment is total. "This is often a very onerous and complicated process, as while certain tests may be carried out on animals, a large number of them have to be carried out directly on humans, notably on patients for whom radiotherapy has failed;"continued Dr Gelet. Something which is easy to design may often be difficult to manage on a human scale, even if patients are widely informed of the benefits and risks involved in the specific case of innovative therapies. As the urologist continued: "No treatment against cancer can have a 700% success rate with zero complications... we are involved in a race whose goal is to improve effectiveness and reduce complications", The objective therefore is to develop the system to move towards an ideal treatment... but this ideal treatment will only be reached step by step. "Even if there are many difficult moments, since our team tests everything new which may be provided, we are absolutely delighted that we now have a machine which works" concluded Dr Gelet.

  Interview with Nathaly MERMET, scientific and medical journalist,for EDAP - March 2006

  A patient's testimonial
  "At 55 years of age, and with a hectic working life, I had a slight cardiac incident which encouraged me to pay more attention to my health, In January 2001, during a visit to my GP, I asked for a PSA test. Result: 15. Oral treatment for prostatic hypertrophy followed by an ultrasound scan with no notable nodules. I didn't see a urologist for another 6 months. A PSA of 25 and a biopsy confirmed the diagnosis I had been fearing. In October 2001 I began 35 sessions of conformational radiotherapy. The trips to and from the clinic were very restrictive and tiring and the secondary effects were difficult to live with, but the treatment got results. The PSA Nadir (minimum reached) was achieved after 12 long months at 0.5. This was followed by check-ups every 4 months for almost 3 years. Meanwhile, I was finding out about my illness and about treatments, I spoke to doctors and my friends and I surfed the Internet a lot. This was when I discovered the applications which use HIFU technology, treatment by focused ultrasound with the Ablatherm device. At the time, few care facilities had the device, not all GPs and urologists were aware of it ... and weren't very happy to be asked questions about innovative techniques by their patients! In November 2004, after a short period of remission, the results of my tests and a new biopsy showed up a relapse, meaning that my radiotherapy had failed and that further treatment was absolutely necessary, Radiotherapy was ruled out because secondary treatment is contra-indicated (unlike HIFU which enables a patient with a relapse to be treated again). My clinical case notes seemed to encourage a catchup (or last chance...) treatment by focused ultrasound, for which the statistics showed very promising results, I'm not sure that my doctor at the time would have prescribed me the treatment which saved my life if I hadn't requested it myself. You have to ask! The centre which usually treated me was supposed to take possession of a latest generated device, but the administration was slowing down the procedure. I then had to spend many long months waiting, until in desperation I went to see a hospital with an excellent reputation, which is a world pioneer in HIFU and at the cutting edge of this type of treatment. After this everything moved very quickly. Examination, visit to the anaesthetist 4 days in hospital then return home under my own steam where I lead a normal life. The treatment which takes around 2 hours, is carried out using a rectal probe under local anaesthetic. Personally I only suffered from a few light secondary effects, little pain and no tiredness. I was treated in January 2006. Until last week I was still waiting for my final results, anxious but above all reassured that I was in the hands of an eminently capable and human specialist who uses a modern technique which is a precursor to tomorrow's medicine and which surely therefore has a great future. My results arrived today (march 2006, 22nd): PSA at 0.01 and negative biopsies! In other words, the Ablatherm HIFU probably saved my life and now I can finally forget my prostate cancer once and for all. My experience was that there were delays in my being taken care of, which is unacceptable when you're suffering from a serious illness. This technique based on the use of the Ablatherm device is available but too few patients have access to it. This is a crying shame! Especially when you know that this technique can save patients like me whose earlier treatments have failed, and that there are certainly too many people who don't have access to it because of a lack of information. I have seen that you must have the right information to be able to talk to doctors and access treatments like HIFU which have proven their effectiveness.

  Patients must have access to information... "
  Alain G., march 2006

  Interview with Sylvie PERRET, journalist for EDAP - March 2006

EAU 2007 Conference Coverage on UroToday.com

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