ULICE Union of Light Ion Centres in Europe

Transcription

1 Project co-funded by the European Commission within the FP7 ( ) Grant agreement no.: ULICE Union of Light Ion Centres in Europe Project type: Combination of CP & CSA Integrating Activities / e-infrastructures / Preparatory phase Start date of project: 1 st September 2009 Duration: 48 months D TNA 11.8 Dedicated Space on the ULICE web site for clinical access WP n and title: WP leader: Author(s): Contributor(s): Pillar coordinator: Reporting period: WP 11 TNA Jürgen Debus Jürgen Debus, Thomas Haberer, Stephanie Combs, Piero Fossati, Marco Krengli Jürgen Debus, Stephanie Combs, Jacques Balosso, Guillaume Vogin, Piero Fossati, Marco Krengli Jürgen Debus 2nd

2 On the ULICE web page, dedicated pages for access have been generated. Within the TA activities, patients from European countries will be treated at the operational facilities. Furthermore, referring radiation oncologists and/or senior researchers will have the opportunity to accompany their patients to the treating facilities and participate in patient treatment planning and the treatment itself. In addition, they will profit from a comprehensive teaching program including target volume definition, treatment planning and beam delivery. Moreover beam time will be made available for radiobiology and physics research for external researchers who do not have an available ion beam in their laboratory. In this framework, researchers from any eligible country can apply to participate in research activities and propose and implement experimental projects in the clinical, radiobiological and physical fields at the University Hospital of Heidelberg (UKL-HD) in Germany and the Centro Nazionale Adroterapia Oncologica (CNAO) in Italy. Eligible external users can apply for transnational access and for successful applicants this will be provided free of charge, via European Union Transnational Access funding. Two types of applications are allowed: - Pre-clinical (Physical and Radiobiological) Research Activity - Clinical Research Activity Transnational Access at UKL-HD At the Department of Radiation Oncology at the University Hospital of Heidelberg (UKL-HD), carbon ion and proton radiotherapy will be offered at the Heidelberg Ion Therapy Centre (HIT). The HIT-facility offers three treatment rooms, two horizontal treatment rooms and one gantry, for proton as well as carbon ion radiotherapy. The gantry is the world s first carbon ion gantry. In addition HIT offers infrastructure for research and development in the field of ion therapy. Labs for medical physics, ion beam technology and radiobiology as well as an experimental cave equipped with a state of the art beam scanning system are part of HIT. In the facility, treatment of over 1300 patients per year with particle therapy will be possible. In Germany, HIT@UKL-HD is the first centre to offer proton as well as carbon ion treatment and is treating patients since autumn The staff has extensive experience in all conventional and modern radiation therapy techniques and has substantial experience with carbon ion radiotherapy. Ongoing research at UKL-HD is in tight connection with the Department of Radiation Oncology at the University Hospital of Heidelberg and the Departments of Radiation Oncology and Medical Physics at the German Cancer Research Centre (DKFZ). ULICE -GA n Page 2 of 8

3 From ion beam technology and medical physics, optimization of ion treatment from beam application, treatment planning and delivery is currently under evaluation. Transfer of novel physical applications into clinical practice in a timely fashion is a main goal. Radiation Biology offers high-end project on a cellular and molecular basis, with special focus on radiobiological effects of high-let beams as well as angiogenesis and molecular responses to radiation therapy. In conjunction with the University Hospitals of Heidelberg and the National Centre to Tumour Diseases (Nationales Centrum für Tumourerkrankungen, NCT) innovative clinical concepts and studies of all phases are being conducted and will have a main focus on the evaluation of carbon ion radiotherapy in a number of tumour entities. With the UKL-HD facility, the unique possibility to perform physical, biological and clinical studies will open new horizons. For clinical evaluations, the facility offers the possibility for large randomized studies on protons, carbon ions and photons alike. For preclinical research HIT offers dedicated infrastructure. Currently, HIT offers proton, carbon and oxygen beams. Within the ULICE TNA Pillar, beam-time at HIT for radiobiological / physics / clinical research projects proposed in the JRA pillar will be available for up to 131 hours. Within JRA, a number of research projects developed to improve and expand carbon ion facilities have been created, some of which require particle beam time at a running facility. Within TNA, beam time for research dedicated to improvement of infrastructures and methodology are distributed by a review committee consisting of experts in the fields. At HIT a dedicated application form has been generated an can be used to apply for beamtime. Research projects allotted with beam time may be projects that have been included in the JRA-pillar, however, which do not receive beam-time through the project financing within JRA; they may also be research project by groups not initially involved in the proposed ULICE framework, which are allocated beam time for their research by the independent review committee. Researchers must define their projects and submit them to the review committee for ranking and approval If you are eligible to apply for Transnational Access, you can download and fill in the Transnational Access application form. Completed forms should be submitted to the ULICE access office: ULICE-access@cern.ch. Download the application form here There are no submission deadlines. Selection procedure Incoming proposals will be examined by the ULICE access office for formal compliance with the EU rules, and then forwarded to a multicentre scientific review committee. The committee meets three times per year to review proposals. ULICE -GA n Page 3 of 8

4 The review procedure will be in two steps: first a go /no-go phase intended to identify proposal that cannot be realized technically. Then a ranking phase in which a score will be assigned to each acceptable proposal and in which the most suitable facility will be selected. The proposal with highest score will be accepted according to foreseen beam time availability.all researchers can at least participate as observers. More direct involvement in patient care will be possible only depending on the researcher status regarding German/Italian laws and rules on medical licences. At UKL-HD/CNAO the internal review panel will verify the practical feasibility of accepted proposals, and in exceptional cases can reject proposals approved by the scientific committee providing adequate justification. The duration of each project will depend on its specific characteristics. For each project, a reference member of will be identified to help the external researchers and support them in their technical and scientific needs. At the end of the project a report will be produced by the external researcher to summarize the performed activities and the obtained results. Criteria for application for pre-clinical research will be: expertise in the field of the proposed research with previous successful work on the proposed topic, high priority of the results for further improvements of currently running and future facilities. Proposals for pre-clinical research will be evaluated with a score ranging from 1 to 5 with the following criteria: Clinical/biological/technical relevance Qualification of the researcher (previous work, expertise) Feasibility of the proposed research Potential to improve existing facilities Impact on hadrontherapy-related issues Proposals will be ranked and a minimum of 15 points are required to be selected. Criteria for application for access to clinical research activities will be: expertise in the field of clinical research in radiotherapy and oncology, potential impact on the future patterns of patient referral and/or of new facilities development. Proposals for clinical trials must fulfill the following criteria: - Medical licence valid in Germany, Board Certification for Radiation Oncology valid in Germany, Board Certification in Radiation Protection valid in Germany, to treat patients - Clinical study protocol adhering to the internal guidelines at UKL-HD/CNAO - Positive vote of the ethics committee of the University Hospital of Heidelberg/CNAO ULICE -GA n Page 4 of 8

5 - Positive vote by the Bundesamt für Strahlenschutz (BfS)/Ministry of Public Health Proposals will be rated on a score of 1-5 for the following criteria: Previous experience in clinical research Practical ability to participate in the clinical activity (language skills and valid license to practice medical activities in Germany/Italy) Potential impact on patient referral Potential to improve existing or new facilities Proposals will be ranked and a minimum of 15 scoring points are required to be chosen. Proposals (3 pages at maximum) should give solid information about preparatory work, reference projects, goal of the experiment and relevance for the field. The review committee will evaluate submitted proposals both for researchers willing to have access to the clinical activity and participating in the ongoing trials and for pre-clinical research requiring beam-time and it will distribute the proposals to the running institutions depending on beam time capacity. The applicants shall be formally informed of the decision by the ULICE access office. If the application is successful the researcher will be advised about the further procedure to follow. Transnational Access at CNAO CNAO is an Italian facility whose mission is to provide hadron-therapy treatments (both proton and carbon ion scanned beams) and to perform research in the related fields. The CNAO synchrotron is able to accelerate proton and carbon ions in the energy range of MeV and MeV/u, respectively, with a beam penetration depth approximately ranging from 3 g/cm 2 to 27 g/cm 2 and steps of 0.1 g/cm 2. Dose is delivered with active raster scanning, GSI-like. Different spot sizes will be available, with a radial size adjustable from 4 mm to 10 mm (FWHM), in steps of 1 mm. The maximum available field size is 20 x 20 cm 2. Up to now, one of the three treatment rooms, equipped with a horizontal fixed beam line, is available for experiments with proton beams in the range of MeV. Moreover, the facility is equipped with one CT scanner, one PET/CT scanner and one 3-T MRI scanner, mainly dedicated to treatment simulation and planning, as well as in-treatment response evaluation and follow-up. Concerning patient positioning, specially designed systems, including both couches and chairs, can be docked to a state of the art, 6 degrees of freedom device. In-room imaging for patient set-up verification can be performed with stereoscopic x-ray kv images of diagnostic quality. Additionally, an optoelectronic system with markers detection and surface detection capability will be implemented. The CNAO centre aims to a high patient through-put. Indeed, the facility design has specifically ULICE -GA n Page 5 of 8

6 addressed this issue and dedicated positioning rooms (Computer Assisted Positioning in Hadron-therapy, CAPH rooms) have been built, adjacent to the treatment rooms. Patients will be positioned on the couch (or on the chair) outside the treatment room, and will be carried in the treatment room on a trolley equipped for docking with the positioning device, thus realizing a time optimization through a pipeline approach. A dosimetry laboratory has been established by the CNAO Medical Physics Unit and includes the most relevant instrumentation (water and solid phantoms, radiation detectors, like as different types of ionization chambers and radiochromic films, multi-channel electrometers, etc.) for physical characterization of high-energy particle scanned beams, as well as for Quality Assurance. A radiobiology laboratory has also been equipped for cell and molecular biology studies. Description of Work 1. Preclinical research. CNAO services and equipments, necessary for the user activity, including the dosimetry and radiobiology laboratories, are available to fulfill the selected project objectives. During the development of the project, the user will be supported by CNAO personnel for technical, scientific and practical aspects. 2. Clinical research. External users participate in running clinical trials that can be explained by internal clinicians. External users will participate in running clinical trials. The design of ongoing and planned clinical trials will be described in the dedicated section both on the ULICE website and CNAO website, to provide needed information for external users access. For external users, an application form can be downloaded and filled in as follows: Research projects allotted with beam time may be projects that have been included in the JRA-pillar, however, which do not receive beam-time through the project financing within JRA; they may also be research project by groups not initially involved in the proposed ULICE framework, which are allocated beam time for their research by the independent review committee. Researchers must define their projects and submit them to the review committee for ranking and approval ULICE -GA n Page 6 of 8

7 If you are eligible to apply for Transnational Access, you can download and fill in the Transnational Access application form. Completed forms should be submitted to the ULICE access office: Download the application form here There are no submission deadlines. Selection procedure Incoming proposals will be examined by the ULICE access office for formal compliance with the EU rules, and then forwarded to a multicentre scientific review committee. The committee meets three times per year to review proposals. The review procedure will be in two steps: first a go /no-go phase intended to identify proposal that cannot be realized technically. Then a ranking phase in which a score will be assigned to each acceptable proposal and in which the most suitable facility will be selected. The proposal with highest score will be accepted according to foreseen beam time availability.all researchers can at least participate as observers. More direct involvement in patient care will be possible only depending on the researcher status regarding German/Italian laws and rules on medical licences. At UKL-HD/CNAO the internal review panel will verify the practical feasibility of accepted proposals, and in exceptional cases can reject proposals approved by the scientific committee providing adequate justification. The duration of each project will depend on its specific characteristics. For each project, a reference member of will be identified to help the external researchers and support them in their technical and scientific needs. At the end of the project a report will be produced by the external researcher to summarize the performed activities and the obtained results. Criteria for application for pre-clinical research will be: expertise in the field of the proposed research with previous successful work on the proposed topic, high priority of the results for further improvements of currently running and future facilities. Proposals for pre-clinical research will be evaluated with a score ranging from 1 to 5 with the following criteria: Clinical/biological/technical relevance Qualification of the researcher (previous work, expertise) Feasibility of the proposed research Potential to improve existing facilities Impact on hadrontherapy-related issues Proposals will be ranked and a minimum of 15 points are required to be selected. ULICE -GA n Page 7 of 8

8 Criteria for application for access to clinical research activities will be: expertise in the field of clinical research in radiotherapy and oncology, potential impact on the future patterns of patient referral and/or of new facilities development. Proposals for clinical trials must fulfill the following criteria: - German/Italian medical licence to treat patient - Clinical study protocol adhering to the internal guidelines at UKL-HD/CNAO - Positive vote of the ethics committee of the University Hospital of Heidelberg/CNAO - Positive vote by the Bundesamt für Strahlenschutz (BfS)/Ministry of Public Health Proposals will be rated on a score of 1-5 for the following criteria: Previous experience in clinical research Practical ability to participate in the clinical activity (language skills and valid license to practice medical activities in Germany/Italy) Potential impact on patient referral Potential to improve existing or new facilities Proposals will be ranked and a minimum of 15 scoring points are required to be chosen. Proposals (3 pages at maximum) should give solid information about preparatory work, reference projects, goal of the experiment and relevance for the field. The review committee will evaluate submitted proposals both for researchers willing to have access to the clinical activity and participating in the ongoing trials and for pre-clinical research requiring beam-time and it will distribute the proposals to the running institutions depending on beam time capacity. The applicants shall be formally informed of the decision by the ULICE access office. If the application is successful the researcher will be advised about the further procedure to follow. In conclusion, access has been offered to the ULICE community and now be allotted to research proposals. ULICE -GA n Page 8 of 8