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RINECKER PROTON THERAPY CENTER STATUS REPORT: CLINICAL OPERATION LICENCE TO BE ISSUED
On 2nd of March 2009, the State Office for the Environment in its capacity as relevant supervisory authority has granted to the RINECKER PROTON THERAPY CENTER the issuance of the operating licence for clinical operation at the first of its five treatment units for treatment of all tumours, that are treatable by radiotherapy (teletherapeutical).
System has passed all official requirements and safety tests.
The technical experts commissioned by the State Office for the Environment and representatives of the State Office carried out 616 test runs on the RPTC system in cooperation with PROHEALTH AG. All complaints have been dealt with and all tests have been successfully completed. The tests addressed general radiation safety of the proton radiation facility, the radiation safety for personnel, the radiation safety for patients, the mechanical safety requirements for patients and personnel, the therapeutic safety of the radiation treatment, and the documentation of the applied irradiation doses. Compliance with corresponding statutory regulations was tested and fulfilled. In particular, the success of software debugging was demonstrated in relation to the performance level of safe therapy at the first of five treatment units of the system. It will be necessary to extend the operating licensing procedure in the future to the other three identical treatment units (gantries) and to the unit for treating eyes and skull (fixed beam).
Therapy performance of the RPTC.
The governmental safety inspection was accompanied by extended radiation simulations carried out by PROHEALTH AG on the system. These tests enabled the specified performance level of the equipment to be verified. As far as we are aware, the system has the highest geometric radiation precision in the world (beam width ~ sigma 3 mm). It utilizes the scanning procedure, which unlike the scattering systems (e.g. the planned facility in Essen) does not radiate any area of healthy tissue outside the target volume with full tumour doses (no excess radiation build-up in the front of the tumour) and allows a conformal radiation of all tumour geometries (concave/convex) . Because the scanning system (again in contrast to scattering systems) avoids preparation of the beam near the patient, no significant neutron radiation strikes the patients. The RPTC numbers among the systems with the highest penetration depth (38 cm) in the world and is therefore in practice not subject to any restrictions in field selection. The beam intensity at the RPTC reduces the radiation time per daily session to optimum values (60-120 seconds). The four gantries at the RPTC permit fields from all directions (by contrast with fixed-beam-only systems) and therefore avoid any compromises in sparing organs positioned in the access area.
Monitored clinical operation but no patient tests at the RPTC.
RPTC exclusively uses proton radiation. This builds on global clinical experience in the administration of more than 50,000 proton radiation treatments worldwide, which have demonstrated a massive reduction in side effects by comparison with conventional X-ray therapy. The reduction in the exposure of healthy tissue to damaging radiation by a factor of 3-5 in comparison with X-ray therapy permits the use of clinically proven dosage increases in the tumour. This enhances the chance of tumour sterilization and cure.
The medical management at RPTC has already made a commitment to make all the treatment data available electronically in strictly anonymized form for the specialist public so that a performance comparison between this method and conventional procedures can be made. Yet, experimental therapy will not be carried out at the RPTC. In contrast with systems being built by universities (Heidelberg, Marburg), no tests and randomized series will be performed using heavy ions instead of protons. The operational philosophy at the RPTC is to give patients access to the verified improvement of proton radiation compared to earlier X-ray methods. This means that the RPTC is focused on patient care other than university systems which shall carry out clinical experiments on patients comparing protons with various heavy ions (carbon, helium, oxygen, etc.) in order to prove or disprove the superiority of heavy ions, that, according to the latest radiobiological data, is doubtful and at best hoped for.
CE certification by manufacturer Varian finally granted.
Previous communications issued by PROHEALTH reported on the manufacturing delay experienced by the project. These delays were caused by the failure to perform by the former ACCEL Instruments GmbH, Bergisch Gladbach. In today’s view these deficiencies concentrated on approximately 100,000 command lines, which constitute only about 5% of the entire software volume. This software functioned smoothly in maintenance mode but operated in clinical mode with an unacceptably large number of safety aborts. The reasons for this concentration of errors are the subject of ongoing investigations. Whatever the cause, they resulted in a work standstill, in the disintegration of the Jenoptik Group as general contractor, and presumably in the sale of ACCEL to the American group Varian Medical Systems, Inc., Palo Alto CA.
Varian, after inspection of the facility, has contractually committed itself to the handover of the first treatment room for clinical operation by June 2007 (!). Meanwhile Varian seems to belatedly establish an appropriately qualified workforce. Subcontractors assisted in debugging the problem areas in the software until maturation (for the operating licence) for the first treatment unit. Adaptation to the parallel operation of several treatment units is currently being carried out. Backlogs and gaps in the area of the documentation that must accompany the production process and is required for the CE certification have turned out to be an ongoing problem. Varian is now attempting to close these gaps in a focused approach with assistance from ProHealth AG and its safety concepts. This is essential for granting the CE certification required for clinical application, which has to be provided by Varian in cooperation with the notified body German Technical Inspectorate (TÜV Rheinland). Varian is currently defining a schedule for the CE issuance that ProHealth regards as not sufficiently robust – in view of the massive exceedance of binding schedules that have been presented in the past. Varian has now also proposed a so called “clinical evaluation operation” for preliminary patient treatment, that might be authorized as soon as October 2008, according to Varian.
By Varian's granting of the CE certification, all these problems are solved now. Apart from software debugging, reconstruction of ACCEL's missing documentation turned out to be the most time consuming process for Varian. Finally, the operating licence could be granted and we are able to receive and treat patients.
Protons, Varian Medical Systems and Healthcare.
Increasing cancer morbidity and a mortality rate, which remains in the order of 50% despite all the improvements to X-ray technology, form the driving force for advancement of radiooncological methodology. Radiation biology and clinical experience indicate that proton irradiation represents one way forward. The RPTC system offers a scanning procedure designed for high treatment capacity that appears to meet all expectations.
It therefore is highly significant for healthcare that Varian as the leading manufacturer of radiation equipment stated in contracts with PROHEALTH and numerous public communications that it would be making a commitment to this advanced technology with the acquisition of the German company Accel and completion of the RPTC. This seemed more important to PROHEALTH AG than for any other potential customer, given that PROHEALTH is planning to replicate the RPTC and has started a follow-up project in Cologne.
RPTC's progression to full performance.
It is intended to increase the performance of the huge facility including diagnostics up to full power step by step. Simultaneous to the increase of patients' demand, this progression is supposed to secure not only an adequate number of trained and qualified personnel, but the step-by-step initial operation of three more treatment units (using the same software and supply of radiation) and, furthermore, a special and smaller dimensioned unit for head and eye treatment. Simultaneously, the amount of time available for clinical application will increase, while the efforts necessary to coordinate the operation of the remaining treatment units will decrease. This delevopment will take up the rest of 2009 and come to conclusion in spring 2010.
Within the same period of time, the incorporation of the RPTC in the form of a cooperating network is accomplished: supported by Medical Practice Dr, Walther, nearby Internistic Clinic Dr. Müller will enhance its service by offering adjuvant (supporting) chemo therapy. Apart from the Center, CHIRURGISCHE KLINIK DR. RINECKER has established a departement specialized in oncological abdominal surgery in order to treat invasive tumours in the abdomen both surgical, if necessary chemotherapeutical and in the most modern radiotherapeutical way at the RPTC. Concurrently, the medical administration of the RTCP tries to extend the cooperation with colleagues for particle irradiation in the domain of proton therapy. For this purpose, an international scientific advisory council will be established. Unfortunately, neither of the two local universities has any expertise (apart from neutrons being used at the nuclear reactor at Munich. The RPTC is not considering this nuclear radiation expertise as a functional addition to the proton technology used here, though). Still our colleagues are interested in an extension of the expertise for particle irradiation at both universities of Munich and, therefore, in a cooperation as well. We have an open mind for these universities' inquiries and submitted corresponding suggestions for cooperative structures. If and as soon as the Bavarian administration has taken positions regarding proton therapy for Bavarian citizens, those plans can be put into practice.
We will provide a news update in the near future.