ENLIGHT Proton and Ion Therapy einfrastructure for health

ENLIGHT ++ Proton and Ion Therapy “e”-infrastructure for health; “e” for “enhanced, enabled, excellent” example of choice: Hadrontherapy Hans F. Hoffmann-PH/CMO 08 November 2006 ENLIGHT++ for Know. ARC project 1

What is Health Definition Health is a state of complete physical, mental and social well being and not only the absence of disease or infirmity WHO Constitution: The enjoyment of the highest attainable standard of health is one of the fundamental human rights of every human being without distinction for race, religion, political belief, economic or social condition WHO Mission The attainment by all peoples of the highest possible level of health 08 November 2006 ENLIGHT++ for Know. ARC project 2

Prospective for cancer therapy… Metastasis Primary tumour Surgery Radiotherapy Conformal RT Medical treatments Hormones; Chemotherapy; Immunotherapy; Cell therapy; Genetic treatments… Novel specific targets (genetics. . ) High LET particles (? ) Survival Quality of life Local control 08 November 2006 ENLIGHT++ for Know. ARC project 3

Hadrontherapy vs. Conventional radiotherapy proton carbon ion Bragg Peak Photons and Electrons Physical dose high near surface Effect not localised Biological effect constant Effective in well oxygenated cells 08 November 2006 vs. Hadrons (protons or light-ions) Dose highest at Bragg Peak Effect is localised DNA damage less repairable Biological effect highest at maximum depth Effective in poorly oxygenated cells (carbon) ENLIGHT++ for Know. ARC project 4

Hadron therapy 28 cm tumour 200 Me. V Protons target / 480 Me. V carbon ions charged hadron beam that loses energy in matter Protons: ocular melanomas, base skull tumours, cancers close to the spinal cord cyclotrons ~ 3 -4 m diameter synchrotrons ~ 6 -8 m diameter GSI XPhotons rays Carbon ions: subset of patients with radio-resistant tumors synchrotrons ~ 20 -25 m diameter 08 November 2006 ENLIGHT++ for Know. ARC project protons or Protons carbon ions GSI 5

Numbers of potential patients From studies in Austria, France, Germany and Italy X-ray therapy every 10 million inhabitants 20'000 pts/year Proton therapy 12% of X-ray patients 2'400 pts/year Therapy with Carbon ions for radio-resistant tumour 3% of X-ray patients 600 pts/year TOTAL of hadron therapy every 10 M about 3'000 pts/year 08 November 2006 ENLIGHT++ for Know. ARC project 6

Hadron therapy status 1954 the first patient treated with protons at the University of California, Berkeley, USA By 2005 about 50000 patients treated. Europe is moving coherently towards the realisation of a network of Hadron therapy Centres with 12 C beams: The two first ones in Heidelberg and Pavia are foreseen to start operation in 2007 France and Austria (approved), Marburg Sweden, Belgium, Netherlands, Spain, UK ………. . Japan has 2 carbon facilities and 4 proton facilities USA has 2 running proton facilities and various others being planned 08 November 2006 ENLIGHT++ for Know. ARC project 7

Hadrontherapy goals Provide the irradiation technology and the detection systems to optimally use the advantageous properties of heavy charged particles in external radiotherapy Optimize dose to tumour conformity by beam scanning and adaptation of the delivery to the organ motion organs at risk tumour Treat > 1000 patients per year and perform clinical trials using low-LET (p, He) and high-LET (C, O) beams Conduct technical, physical and clinical R+D tumour-conformal dose distribution 08 November 2006 ENLIGHT++ for Know. ARC project 8

What is ENLIGHT 2002 -2005 ENLIGHT (European Network for Light Ion Therapy) ENLIGHT was composed of: Centres in Heidelberg, Lyon, and Pavia, CERN, EORTC, ESTRO, GSI, Karolinska, Med. Austron, TERA Main achievements: • Creation of a European Hadron therapy Community • Common multidisciplinary platform with a shared vision • ENLIGHT catalysed the transition from research to the clinical environment • Served as a vehicle for education and dissemination 08 November 2006 ENLIGHT++ for Know. ARC project 9

What is ENLIGHT++ In 2006 ENLIGHT++: + one “plus” for more hadrons (specifically protons), ++ the second “plus” refers to more Countries (17 countries, with 60 Institutions ENLIGHT++ goes beyond being a network: Main Objective: challenge for quality and success by being more inclusive and becoming a research network and an FP 7 project 08 November 2006 ENLIGHT++ for Know. ARC project 10

Present European projects on the same scale Med. Austron ETOILE CNAO / TERA HICAT 08 November 2006 ENLIGHT++ for Know. ARC project 11

ENLIGHT++ strengths Success of original ENLIGHT and other pre-existing cooperation Top research institutes Scientists working at the cutting edge of knowledge and technologies Expectations of cancer patients 08 November 2006 ENLIGHT++ for Know. ARC project 12

ENLIGHT++ ingredients Networking light ion research: Clinical Studies Radiobiology Treatment planning for Intensity Modulated Particle Therapy Adaptive ion therapy and treating of moving organs Novel in-beam PET systems Feasibility study for innovative gantry designs Information and Communication Technologies for Hadron therapy (this presentation!) 08 November 2006 ENLIGHT++ for Know. ARC project 13

Outlook Particle therapy will cover the full spectrum of radiotherapeutical indications Per 10 million inhabitants one particle therapy facility may be required Treatments will be fully accepted by the health insurance systems Pilot “European application of e-Health”? 08 November 2006 ENLIGHT++ for Know. ARC project 14

ENLIGHT++ challenge A heterogeneous group - 7 different disciplines. How to a balance between basic research and the clinical needs? Many partners. How to collaborate effectively and make progress with the main objectives Is ion therapy more effective? Will practice validate theory? Here: Is Hadrontherapy particularly appropriate for a pilot ICT e-health infrastructure? ? 08 November 2006 ENLIGHT++ for Know. ARC project 15

e-Health: Health Care enhanced by ICT “e-Health”, Healthcare “enhanced” by ICT, deals with the use of ICT to develop intelligently connected infrastructures (very likely “ grids”) that provide: "the right information, at the right time, in the right place" For ubiquitous management of citizens’ health To assist health professionals To integrate advances in health knowledge into clinical practice To streamline the citizens' healthcare system and To empower the patients to take informed decisions for their wellbeing e-Health is an obvious necessity e-Health is also excellent business 08 November 2006 ENLIGHT++ for Know. ARC project 16

There are many issues “in the German Health care system every institution in itself is an isolated solution, partially in line with the latest scientific research, but singular. As a rule, the limits of ICT are reached where the resources of one’s own institution are exhausted” (BM Gesundheit) Making data available in electronic patient records Security, authentication, access control, anonymity. . . Using the same vocabularies, ontologies. . . Provision of sufficient computers and networking infrastructure to Doctor’s practices and hospitals Clinical data restrictions, FDA, (21 CFR part 11. . . ), Also , national practices, . . . Adopting ideas of Collaboration in the Health community and many other issues. . . But the promise is great. . . and the time is right 08 November 2006 ENLIGHT++ for Know. ARC project 17

Ingredients of e-health infrastructure items Patient card Specialist card Patient file Prescription Mobile diagnostics attached to patients (RFID, Bluetooth, GSM, . . . ) Referral system between hospitals Security, privacy, . . . Distributed data storage Standardised data curation Standard interfaces Computers Networks Patient empowerment Networked solutions 08 November 2006 ENLIGHT++ for Know. ARC project 18

Health. Grid: Research Vision Computing Grid For data crunching applications Ø An environment, created through the sharing of resources, in which heterogeneous and dispersed health data : Ø molecular data (ex. genomics, proteomics) Ø cellular data (ex. pathways) Ø tissue data (ex. cancer types, wound healing) Ø personal data (ex. EHR) Ø population ( ex. epidemiology) Ø as well as applications, can be accessed by all users as an tailored information providing system according to their authorisation and without loss of information. Data Grid Distributed and optimized storage of large amounts of accessible data Knowledge Grid Intelligent use of Data Grid for knowledge creation and tools provisions to all users

Health. Grid: State-of-the art and next steps Current applications Next application fields Computing Grid Image analysis Ex. : Mammo. Grid Real time operational assistance Modeling, simulation, algorithms Ex. : Gemss, Data Grid, Cross. Grid Radiotherapy Disease related Grids Drug discovery Epidemiology Image storage and accessibility Ex. : Mammo. Grid Data Grid Bio-informatics Ex. Bio. Grid Knowledge Grid

Health. Grid: Research Challenges Ø Highly Distributed sources of health data, with strong privacy rules Ø Semantic integration - building on the results related to Ø interoperability of Electronic Health Records and research data Ø Algorithms for search, data mining and knowledge retrieval based on Ø advances in language understanding Ø Privacy and Security Ø Adopting existing solutions to the Grid Ø High reliability of system must be proven Ø User friendliness and acceptance Ø Need to provide fast and easy to use tool at the point of need Ø Very heterogeneous user community - health professionals, researchers, authorities, patients Ø Organizational and cultural issues related to new ways of working and Ø virtual collaborations Ø From technology to a solution in Healthcare Ø Political awareness and understanding Ø Business models Ø Legal and ethical issues

Health. Grid: Implementation questions 1) 2) 3) 4) 5) 6) 7) What could be the role of Health. Grid in meeting the challenges in managing the rising costs, growing demands from consumers (patients; citizens) and demographic changes, aging population? Can Health. Grid play a role as an enabling tool for reorganisation of the healthcare systems and can the needed training be provided ? How can we assure a maximal user acceptance and user friendly technologies and standards ? What is needed in order to be able to promise respect of legal, security and privacy ? Do we have convincing proofs today or is there still homework to be done ? Can we convince industry to invest in Health. Grid and which part of it ? Can Health. Grid find its place in the general strategy of health information networks ? Can it become a leader ? Can Health. Grid find its place in the general strategy of online health services ?

ENLIGHT++ - Meeting, CERN, March 24 th, 2006 Reflections on requirements of ehadrontherapy (T. Auberger‘s (radio-onkologist‘s) slides) WP 7 – ICT Network for Particle Therapy Requirements are the domain of the users of a project: What to achieve Specialists: How to do it Execution: in continuous collaboration 08 November 2006 ENLIGHT++ for Know. ARC project 23

Two Versions of Network for Particle Therapy Ø network of European ion therapy centres Ø national network between user groups and a central ion therapy centre 08 November 2006 ENLIGHT++ for Know. ARC project 24

Questions Why do we need a network? What is necessary for an European network and for a national network ? What do we have to do? Proposals ? What do we need for our work ? 08 November 2006 ENLIGHT++ for Know. ARC project 25

Why do we need a network? I) European Network of Ion Therapy Centres Communication between European ion therapy centres Video conferences replace meetings Exchange of know how Mutual treatment strategies and protocols Exchange of technical parameters Unique definition of treatment parameters Standardized technical parameters 08 November 2006 ENLIGHT++ for Know. ARC project 26

Why do we need a network? I) European Network of Ion Therapy Centres Preparation of clinical multi-centre trials Input of patient and treatment data, diagnostic imaging, image fusion, comparisons of treatment planning online planning Mutual data library rare tumour entities unique statistics 08 November 2006 ENLIGHT++ for Know. ARC project 27

Why do we need a network? I) European Network of Ion Therapy Centres Coordination of non clinical research Mutual scientific proposals Distribution of beam time and programmes (i. e. for radiobiological research of countries which don’t have facilities) 08 November 2006 ENLIGHT++ for Know. ARC project 28

Why do we need a network? II) National network between user groups and a central ion centres (1) Information and training of users (peripheral hospitals) Definition of standards on diagnostic and clinical preparation of patients Nationwide and bilateral video tumour boards Rapid exchange of patient and treatment data (mutual electronic patient files? ) 08 November 2006 ENLIGHT++ for Know. ARC project 29

Why do we need a network? II) National network between user groups and a central ion centres (2) Adjustment of treatment modalities in combined therapy regimes (summarizing doses from different treatment plans, online treatment planning ) Patient preparation and follow-up under observation of ion centres National tumour libraries 08 November 2006 ENLIGHT++ for Know. ARC project 30

What is necessary for an European network and for a national network ? Common structure in medical and scientific strategy Unique acquisition of patient and treatment data Unique definition of beam and planning data European clinical study protocols Necessary technical support Telecommunication systems Unique electronic patient files ? unique treatment planning systems ? image data and planning data transfer one mutual definition on software for international trials 08 November 2006 ENLIGHT++ for Know. ARC project 31

What do we have to do? Medical and scientific structure Evaluation of the national medical infrastructure in various European countries Technical solution, which regards this existing infrastructure or alternative ways 08 November 2006 ENLIGHT++ for Know. ARC project 32

What do we have to do? Medical and scientific Structure mutual treatment strategies and guidelines for preparation of patients, diagnostics, follow-up preparation of unique clinical trials regarding system not contents (protocols) ? tumour libraries (indications? –what has to be stored and how? ) organisation of non-clinical research (if appreciated? ) 08 November 2006 ENLIGHT++ for Know. ARC project 33

What do we have to do? Evaluation of national medical infrastructure in various European countries video tumour boards organisation of patient preparation and follow-up documentation of treatment results data formats patient files and imaging data (storage, transfer) electronic communication systems Compatibility of treatment planning systems electronic epidemiologic registries Software for support of clinical studies (ARCS ? , other commercial and non-commercial systems? ) 08 November 2006 ENLIGHT++ for Know. ARC project 34

What do we have to do? Technical solution commercial and non commercial systems (advantages and disadvantages) costs and requirements of installation compatibility with existing infrastructure and running or planned technical equipment 08 November 2006 ENLIGHT++ for Know. ARC project 35

Proposals Learn from - integrate existing projects: Mammogrid Health-e-child. . . 08 November 2006 ENLIGHT++ for Know. ARC project 36

What do we need ? Experts/scientific assistants on radio oncology medical physics ICT Reimbursement of Travelling costs Communication costs Software/hardware ? (hfh): Connect “stand alone” solutions, solve, satisfy: Private interests of firms providing case solutions Limited/local perspective of the users IP 08 November 2006 ENLIGHT++ for Know. ARC project 37

Conclusion for Enlight++ e-infrastructure There are various reasons to build up an international network and national networks as well Step 1 - (medical point) development of a common medical and scientific strategy Step 2 – (medical, technical) evaluation of current national infrastructure Step 3 – (technical) evaluation of a technical solution for an international network which goes ahead with national development Step 4 – (medical, technical) pilot projects which will prove the efficiency of proposed solutions 08 November 2006 ENLIGHT++ for Know. ARC project 38