Research Group: Therapy Planning - Application
Group Leader: Angelika Höss
Summary of Research Projects
The task of the working group is the integration, pre-clinical testing, support, maintenance and quality assurance of software modules and packages designed for 3D treatment planning which have been developed by members of the Department of Medical Physics in Radiotherapy and are afterwards put at the disposal of the Clinical Cooperation Unit Radiation Oncology (E050) for clinical testing. The VOXELPLAN project, initially funded by the Deutsche Krebshilfe, has demonstrated impressively the scientific and clinical potential of the software packages developed by the Department of Medical Physics in Radiotherapy. The unique research environment given in the Research Program Radiological Diagnostics and Therapy enables an interdisciplinary close cooperation of physicians, physicists and computer scientists resulting in a direct benefit to thousands of cancer patients treated with 3D conformal radiotherapy and intensity modulated radiotherapy in clinical trials at DKFZ and at the sites of its cooperation partners. In addition to this major clinical activity the software packages supported by the group serve as carrier systems for research activities of members of the Department of Medical Physics in Radiation Oncology as well as of their national and international scientific cooperation partners.
Until recently, there have been few regulations in Europe concerning medical equipment, and there still is a lot of uncertainty on behalf of "manufacturers" of "medical devices" like DKFZ, if and how to employ the new Medizinproduktegesetz and its ordinances derived from the European Medical Devices Directive (93/42/EWG). As the medical devices built by the Department of Medical Physics in Radiotherapy are not "placed on the market", but only "put into service" within the Clinical Cooperation Unit Radiation Oncology they do not need to bear the CE mark indicating that they have been subjected to a conformity assessment procedure. However, the obligation remains to keep the risk to the patient justifiable compared with the potential benefit, and to carry out quality assurance procedures complying to state-of-the-art safety standards and applicable law. As there is also an obligation to notify the authorities about the manufacturing, servicing or marketing of medical devices - and to report any incidences - the competent authorities were contacted and a preliminary certificate of exemption for the further clinical application of radiotherapy equipment manufactured in-house was obtained. Due to ongoing efforts by the legislator to facilitate compliance with the new regulations by enacting and modifying specific laws and ordinances, the working group is following up the state of affairs and fulfilling the associated qualifications (e.g. compilation of medical devices books).
During the period under report a completely revised, UNIX based version of VOXELPLAN was implemented, tested and finally released for clinical evaluation - in conjunction with the IMRT software package KonRad - in close cooperation with the working groups "Therapy Planning - Development", "Physical Models" and "Biophysics and Radiotherapy Physics". This new version compensates any known shortcomings of its predecessors and contains a wide range of new features and functionalities to simplify and speed up treatment planning procedures and to facilitate the introduction and evaluation of new irradiation techniques. Supplemental quality assurance tools have been implemented to check the correctness and reliability of the planning systems as well as the consistency and integrity of the patient data and devices parameters which are all decisive for the quality of the resulting treatment plans. These tools can be employed to monitor the quality of such systems, and to direct quality assurance activities. However, although the development and application of dedicated treatment planning software is a major clinical activity of the Department of Medical Physics in Radiotherapy, the efforts to shift routine work to commercially available systems were further intensified due to the additional expenses - in terms of manpower and other resources - caused by the obligation to comply with regulations during the permanent operation of non-CE certified systems, and especially when newly developed software is put into service. The objective is to ensure the availability of the in-house systems for research purposes - provided that the resources remain constant - by discharging them from as many routine tasks as possible. The working group therefore also covers the commissioning, operation, servicing and quality assurance of the CE certified treatment planning systems available at DKFZ.
In cooperation with:
Prof. Dr. N. Ayache, INRIA, Sophia Antipolis, France;
Prof. Dr. M. Bamberg, Dept. for Radiotherapy, University of Tübingen;
Dr. M.L. Bahner, Dept. of Oncological Diagnostics and Therapy, DKFZ;
Prof. Dr. H. Blattmann, Paul Scherrer Institute, Villigen, Switzerland;
Dr. J. Bohsung, Dept. of Radiotherapy, Charité, Berlin;
PD Dr. T. Bortfeld, Dr. R. Bendl, Prof. Dr. G. Hartmann, Dept. of Medical Physics in Radiation Oncology, DKFZ;
PD Dr. Dr. J. Debus et al., Clinical Cooperation Unit Radiation Oncology, DKFZ;
Prof. Dr. R. Felix, PD Dr. P. Wust, Virchow-Klinikum, Berlin;
Dr. D.T.L. Jones, Dr. A.N. Schreuder, National Accelerator Centre, Faure, South Africa;
Prof. Dr. G. Kraft, Gesellschaft für Schwerionenforschung mbH, Darmstadt;
MRC Systems GmbH, Heidelberg;
Prof. Dr. G. Nemeth, Dr. O. Esik, National Institute of Oncology, Budapest, Hungary;
Nucletron B.V., Veenendaal, The Netherlands;
Prof. Dr. F. Nüsslin, Dept. of Medical Physics, University of Tübingen;
B. Rhein, P. Häring, Dept. of Biophysics and Medical Radiation Physics, DKFZ;
Prof. Dr. J. Richter, Clinics for Radiation Therapy, University of Würzburg;
Prof. Dr. L. Schad, Dept. of Biophysics and Medical Radiation Physics, DKFZ;
Dr. S. Scheib, Klinik Im Park, Zurich, Switzerland;
Prof. Dr. R. Schmidt, Dept. of Radiotherapy, University Hospital Eppendorf, Hamburg;
Dr. U. Schneider, Clinics for Radiooncology and Nuclear Medicine, Zurich, Switzerland;
Stryker Leibinger GmbH, Freiburg;
Prof. Dr. V. Sturm, Dept. for Stereotactic & Functional Neurosurgery, University of Cologne;
Prof. Dr. M. Wannenmacher, Radiologic University Hospital, Heidelberg;
Prof. Dr. S. Webb, Dr. J. Bedford, Royal Marsden Hospital, Sutton, Great Britain;