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Development and Cooperation Research Programs at HIMAC

This article provides an outline of the HIMAC project, previous achievements, present developments, and the framework of cooperation research. It covers the construction of the research facility, registered patient numbers, carbon-ion radiotherapy network committees, clinical study protocols, and more.

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Development and Cooperation Research Programs at HIMAC

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  1. NIRS HIMAC Development and Cooperation Research Programs at HIMAC Contents: 1. Outline of HIMAC project 2. Previous achievements 3. Present developments 4. Framework of cooperation research A. Kitagawa Leader, Promotion of Heavy Ion Radiotherapy Team (Senior Researcher, Dept. of Accelerator and Medical Physics) Research Center for Charged Particle Therapy National Institute of Radiological Sciences

  2. 1. Outline of HIMAC project

  3. 1. Outline of HIMAC project • Japanese government • Ministry of Health • Ministry of Education • Science & Technology Agency • Ministry of Education, …, • Science & Technology • (MEXT) HIMAC project Strategy Comprehensive 10-Year Strategy for Cancer Control 1984 1st 1994 2nd 2004 3rd 2014

  4. Construction of research facility 1. Outline of HIMAC project Feasibility study ‘84 ‘85 ‘86 ‘87 ‘88 ‘89 ‘90 ‘91 ‘92 ‘93 ‘94 Design of machine Survey Research & developments for devices technology (incl. biology) Design of Buildings Machine Construction of Buildings Buildings Installation of Utilities Buildings Manufacturing & installation of machine Electricity, cooling system, … Injector commissioning Synchrotron Research Irradiation system,… Physics & Biology Clinical trials “Summary at the 10th anniversary of the heavy ion radiotherapy”, edited by MEXT, Monbu-Kagaku Jihou No.1541, August 2004, pp. 10-49. (in Japanese) Ion species: He – Ar (He – Si for clinical) Treatment room: 3 (4 port) Experiment room: 2 (3 port) Size: 60 x 120 m Construction cost: 32.6GJPY (Building 14.6GJPY) (machine 18.0GJPY) *GJPY ~10MUS$

  5. 2. Previous achievements

  6. Registered patient number 2. Previous achievements 804 692 684 691 642 648 549 437 396 333 1463 patients have been treated from June 1994 to March 2003 Ministry of Health approved carbon-ion radiotherapy as ‘Advanced Medicine’

  7. 2. Previous achievements Carbon Ion Radiotherapy Network Committee Head&neck, Central nervous system, Lung, Liver, Urinary organs, Gynecological region, Bone&soft tissue, Eye, Pancreas, Lower gastrointestinal tract, Upper gastrointestinal tract Planning Committee Subcommittee by body parts　 Organizing of clinical study protocols Preparation of protocols by body parts Evaluation Committee Evaluation of therapeutic results Head&neck, Central nervous system, Lung, Liver, Urinary organs, Gynecological region, Bone&soft tissue, Eye, Pancreas, Lower gastrointestinal tract, Upper gastrointestinal tract Research Center for Charged Particle Therapy Clinical Study Ethical Committee　 <Hospital> Review of the entire treatment flow Review of eligibility - Medical examination - Informed consent Ethical Radiotherapy Committee Advanced Medical Technology Review Committee Clinical study group Other medical institutions Review of individual patients Planning, Follow-up <HIMAC> Irradiation Carbon Ion Radiotherapy Indication Committee Organization of clinical trials in NIRS “Progress to date in carbon ion radiotherapy - Present status and outlook”, edited by NIRS, Radiological Sciences Vol.50 No.7, July 2007, pp. 4-65.

  8. 2. Previous achievements X-ray CT PET before 1 year after before 5 years after Summary of clinical results • Carbon ion radiotherapy has 3 large advantages, Better local control / survival ratios Hypo-fractionation: shorter treatment period 1 day treatment 1 fraction ~50.0GyE in 1 day 3 year Local control 83% 5 years survival 55% (mean age=73.9) cause specific survival 73% 5 years overall survival ratio in inresectable cases 46% (<500cc), 19% (>500cc) Lower toxicities Delayed adverse reaction (>=G2) 0.3% (Rectum) 2.4% (Genitourinary system) Publications D. Schulz-Ertner and H. Tsujii, Journal of Clinical Oncology, 2, 953 (2007). H. Tsujii et al., New Journal of Physics 10, 075009 (2008). H. Tsujii and T. Kamada, Jpn. J. Clin. Oncol. 42, 670 (2012). Recent clinical results like NIRS-MedAustron Joint Symposium http://www.nirs.go.jp/ENG/publication/

  9. 2. Previous achievements Waveguide Gas inlet Mirror magnet 500l/sTMP Plasma chamber Extraction electrode (movable) Sextupole magnet High voltage platform 500l/sTMP Acceleration gap (Insulator) Einzel lens Analyzer magnet Faraday Cup & Slit Extension for heavier ion species 18GHz NIRS-HEC ECRIS

  10. 2. Previous achievements Extention of experiment rooms

  11. Time sharing acceleration 2. Previous achievements Example of operation time (April 2009 - March 2010) E INJ E USY UBT E LSY E Treatment Rooms E E LBT Schematic diagram of HIMAC HIMAC can provide individual beams for three different users at the same time. Failure rate: INJ=0.7%, USY=0.1%, LSY=0.1%

  12. 2. Previous achievements 15O 12C 13N 11C 11C 12C 11C, 10C ... Medical application of radioisotope beams Principle of the measurement Production method of RIB b+emitting nuclei Method 1 decay Method 2 positron Method 3 Observation of a pair of annihilationg-rayfrom outside of patient Human body Methods of production for b+ 1. In-vivo activation method: Stable beam produces b+-emitter as target fragment. 2. Autoactivation method: Stable beam changes to b+-emitter as projectile fragment. 3. Radioactive nuclear beam method: directly shows it’s position with high signal-to-noise ratio. 1G.W. Bennett et al.., Science 200, 1151 (1978). / 2C.A. Tobias et al.., Int. J. Radiat. Oncol. Biol. Phys. 3, 35 (1977). / 3A. Chatterjee et al.., Int. J. Radiat. Oncol. Biol. Phys. 7 (1981) 503.

  13. 2. Previous achievements 10C 11C 10C 11C Absorber (PMMA) Fast component 1 Brain 15cm Blood flow 10C / 11C Intermidiate component 2 20cm Component-1 τ~10±8s （30±4 %） Component-1 τ~2.0±1.8s （35±3 %） Component-3 τ~10191±2200s （35±1 %） Plastic Scintillator Cell Component-3 τ~3175±378s （52±2 %） Muscle 12cm Slow component 3 Component-2 τ~140±18s （30±3 %） Component-2 τ~195±52s （19±3 %） Trials at HIMAC 1-D range information in the PMMA phantom Beam condition 10C & 11C beam energy : 346 MeV/u (range=156.9mm in PMMA) Momentum width : 0.8% (FW) (Drange=3.6mm) Beam size : 7 mm (FWHM) Intensity : 300-500k pps (110-180mGy) 0.95*diameter Range shifter spherical PMMA (150, 180 diam.) Accuracy of the centroid of the stopping point in the phantom = 0.6 mm 10C / 11C Plastic scintillator Y. Iseki et al..,Phys. Med. Biol. 49 (2004) 1 Metabolism study by rabbits alive rabbits Beam condition 10C & 11C beam energy : 346 MeV/u Momentum width : 0.4% (FW) Beam size : 3 - 7 mm (FWHM) Intensity : 24k (10C) pps 300k (11C) 3-components Biological model of wash out dead rabbits H. Mizuno et al.., Phys. Med. Biol. 48 (2003) 2269.

  14. 2. Previous achievements multi-leaf collimator ridge filter pencil beam collimater PSD monitor positron camera position monitor Q Magnet scatterer dose monitor (main/sub) range shifter patient chair scanning magnets (h. & v.) 5430mm 3-D irradiation system Position scanning in a slice by the scanning magnets Range scanning by the range shifter Beam energy from the accelerator is fixed Maximum scanning volume 10 x 10 x 18 cm (WE) Scanning speed (x, y) 2 ms/cm But, it’s difficult to utilize moving target! E. Urakabe et al.., Jpn. J. Appl. Phys. 40 (2001) 2540.

  15. 3. Present developments

  16. 3. Present developments Ion source Linac Synchrotron Magnet Acc. cavity Irradiation system Magnet power supply Developments of prototypes (2004-2005) Design concept: Optimization for carbon beam only!! 1/3 Size and Cost of HIMAC K. Noda et al., J. Radiat. Res. 48:Suppl.A A43 (2007).

  17. 3. Present developments ‘01 ‘02 ‘03 ‘04 ‘05 ‘06 ‘07 ‘08 ‘09 ‘10 Project funded by Japanese government Feasibility study Survey Feasibility study & fundamental design (at NIRS) Developments of devices Machine & Buildings Manufacturing Design of machine and Buildings Machine Buildings Construction of Buildings Buildings Installation of Utilities Electricity, cooling system, … commissioning Manufacturing & installation of machine Injector Synchrotron Irradiation system,… Clinical trials Clinical trials Gunma University Project (2006-2010) • Demonstration of the hospital-specified facility • - Dedicated carbon beam only • with max. 400MeV/u & 1x109pps • Wobbler & layer-stacking irradiation systems • Technology transferred to manufacturing companies • Construction cost (machine&building) • ~ 12 GJPY *GJPY~10MUS$ Gunma University Heavy ion Medical Center T. Ohno, Cancers 2011, 3, p.4046.

  18. Comprehensive Strategy 3. Present developments • [3rd Comprehensive 10-Year Strategy for Cancer Control, 2004-2013] • 2004 “Workshop for popularization of the charged-particle radiotherapy” was held by MEXT and the summary report has been distributed. • 2005 “The guideline for charged particle radiotherapy in Japan” has been authorized by the Japanese Society of medical Physics (JSMP). • 2004-5 Design of a hospital-specified facility and development on prototypes of various components at NIRS was funded by MEXT. • 2005-7 “Research on radiation protection for proton and heavy ion radiotherapy” was funded by MHLW. • 2006-10 Construction of the 3rd facility at Gunma University as a demonstration model was funded by MEXT. • 2007-12 “Program for the Human Resources Development Relating to Charged Particle Radiotherapy” has been funded by MEXT. • 2007- Approved the construction of “the next-generation irradiation systems” at NIRS. • 2010 First treatment at Gunma University. • 2011 Start of clinical trials with the respiratory gated 3D scanning at NIRS.

  19. Present facilities 3. Present developments GHMC Gunma (2010) SAGA-HIMAT Saga (2013) HIMAC Chiba (1994) iROCK Kanagawa (2015) HIBMC Hyogo (2001) Heavy ion Heavy ion (under construction) Proton (including shutdown) Proton (under construction) Other plans

  20. 3. Present developments III. Scanning with respiratory gate Head, Prostate, Lung, Liver… Research topic of irradiation methods Target volume Unexpected dose II. a) Scanning I. a) Wobbler I. b) Layer-stacking wobbler II. b) Scanning without respiratory gate Head, Prostate, Lung, Liver… Head, Prostate, Lung, Liver…

  21. 3. Present developments 2011 Gold Award New research buildings For various research, the new treatment research building has been constructed. The clinical trial of a fast 3D-scanning irradiation system as the next-generation irradiation technology started since 2011. New facility HIMAC Hospital

  22. 3. Present developments Operation summary of new facility Targets in 2012

  23. Treatment planning system 3. Present developments Step 2: Extra-dose to Optimization Step 1: Scan Path Optimization Application of simulated annealing algorithm Delivered beam Effective higher than 108 pps T. Inaniwa et al., Med. Phys. 34, 3302-3311 (2007)

  24. New patient positioning system 3. Present developments Residual positional error in 2011 Treatment time for one patient (old system ~ roughly 25 min.) S. Mori et al, Journal of Radiation Research, 53, 760 (2012).

  25. Experimental Study on respiratory gating 3. Present developments • Moving phantom 24ch pinpoint chambers in water Comparison Plan - Measurement 8 rescans dD/D < 1.7% Physical Dose : 1 Gy, Respiratory cycle : 4.3 s, Amplitudes : 7 mm (20 mm ungated). T. Furukawa et al., Med. Phys. 37, 4874 (2010) Y. Shirai, Proc. NIRS-MedAustron Joint Symposium (2013).

  26. 3. Present developments Example of new developments Y. Iwata et al.., Proc. IPAC2011, 3601 (2011). Y. Iwata, Proc. NIRS-MedAustron Joint Symposium (2013).

  27. 3. Present developments 10% Biological model for treatment scattering LET dose LQ model reaction • If, • Uniform irradiation field • Parallel beam depth HSG survival dose • But, • Human body has nonuniform density. • Real beam has spatial distribution, divergence, contamination of impurity, etc… depth

  28. MKM model for microscopic understanding 3. Present developments Rn Track structure model (Kiefer and Chatterjee) rd rd • Cell nucleus is divided into many independent sub-volumes. • Dose response in the sub-volume is independent on radiation type. • Cell responseis given by the sum of the lethal events in all sub-volumes. • Parameter search is necessary • Adequate model size • Incident dependent term • Target dependent term • Overkill correction • Etc…. extrapolated for LET=0 constant N. Matsufuji, Proc. NIRS-MedAustron Joint Symposium (2013).

  29. 4. Framework of cooperation research

  30. PAC and evaluation of the proposals 4. Framework of cooperation research Call for proposals All proposals! NIRS researchers follow the same process Twice every year Submit proposals PAC evaluates all proposals PAC When accepted Scheduling of beam time Announcement of beam time ½ year schedule

  31. Number of proposals in each year 4. Framework of cooperation research Rough breakdown of beam time Industrial use ~ less than 1 % Beam time ~ 5000 hours / year

  32. Weekly schedule 4. Framework of cooperation research Mon Tue Wed Thu Fri Sat Sun Upper Ring Lower Ring Linac • Typical schedule • Therapy • Biology • Physics or others • Maintenance (No Beams) • Monday • Maintenance • or • Treatment • Weekdays(daytime) • Treatment ~10h • Weekdays(night) • Experiment ~10h • Weekends • Experiment ~24h • Sunday • Shutdown • or • Experiment • 1 month shutdown • Twice per year (March & August) • Maintenance • Commissioning of new devices • Treatment=180 days/year

  33. 5. Example of experiment

  34. Visualization of the track in scintillator 5. Example of experiment • Visualizing the track of single ion in a scintillation material for… • Quality assurance in particle radiotherapy (transmitted particle detection) • Understanding of radiation quality of therapeutic ion beams • Understanding of fundamental physics • inter- and intra-nucleus transportation of ions • Track structure Range analysis Single ion track detection (C-290MeV/n)

  35. Visualization of track structure 5. Example of experiment Fe horizontal J375 XLF 1Gy 30min after irradiation Track in the cells, visualized by fluorescent marker Xray Courtesy of Nakako Nakajima, NIRS.

  36. Hyperfine study 5. Example of experiment In-beam Mössbauer spectroscopy of 57Fe/57Mn 58Fe Emission Mössbauer spectra of 57Fe in MgO 57Mn The reproducibility of the primary beam was checked by a pair of multi-wire proportional chambers installed at the production-target position. The reproducibility of the radioactive beam was confirmed by the measurement of TOF-E. A typical switching time from the therapy to the RIB irradiation on the experimental sample is less than one hour except for the ion source preparation. Independent ion sources are usually assigned for the therapy and the experiments.

  37. 5. Example of experiment Installation of local injector Prototype injector for the hospital-specified facility • It has been developed and tested in March 2006. • It has been installed for the local injector into HIMAC in 2011. • Presently, it supplies carbon beam for experiments

  38. Summary • HIMAC project is carried out under the comprehensive strategy and is covered the budget of government. • About 8000 patient has been treated and the facility has been utilized for various developments and research. • Between 2004 and 2013, the promotion of carbon ion radiotherapy is 1st priority. Other developments the new irradiation techniques are in progress. (Of cause, improvements of clinical protocols too) • Many developments and research are carried out under the framework of cooperation research. About 5,000 hours are delivered

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