1. ENEA Radiation Protection Institute and ENEA “Health project” for radiation protection in medicine Elena Fantuzzi ENEA Biotechnologies, Agro-industry and Health Protection Department Radiation Protection Institute Italy Information Meeting on “Medical uses of radiation in diagnosis&therapy” EUROPEAN COMMISSION Directorate J-Energy (Euratom) Unit2: Fission Brussels, 31 January 2007 Radiation Protection Institute

2. ENEA Radiation Protection Institute ENEA scientific activities are organized in 5 Departments. Radiation Protection Institute (RPI) Biotechnologies, Agro-industry and Health Protection The Radiation Protection Institute (RPI) belongs to the Department of “Biotechnologies, Agro-industry and Health Protection” and it is present in 5 ENEA Research Centres with its own staff. IRP currently employes about 60 people: 25 researchers +35 technical staff. In 1993 all the ENEA activities in the radiation protection fields were combined to create the Radiation Protection Institute. The institute consists of the research activities, mainly carried out in the ENEA research centre of Bologna with the support of the radiation protection laboratories and services located in the ENEA research centres of Casaccia, Frascati, Saluggia and Trisaia.

3. ENEA Radiation Protection Institute Activities R&D in radiation protection R&D in radiation protection, mainly related to ionizing radiation dosimetry and radiation safety at Fusion energy facilities e.g. biokinetic modelling for internal dosimetry, radiation transport calculations, solid state dosimeters, radiation protection methodologies for advanced nuclear facilities (nuclear fusion), radiobiology studies. => Qualification of measurement techniques and methodologies => Qualification of measurement techniques and methodologies, by contributing to national and international standards development, harmonization of radiation measurement and dose evaluation procedures Radiation protection surveillance at ENEA sites Radiation protection surveillance at ENEA sites to fulfil law obligation by means of its Qualified Experts, Operates laboratories for the calibration of survey monitors, the individual monitoring of the internal contamination (whole body counters, alpha, beta, gamma and ICP-mass spectrometry), the personal dosimetry for external exposure (track and thermo- luminescence dosimetry services) and radon concentration evaluation service, assures the environmental surveillance for the ENEA research reactors

4. Dosimetry laboratories and available techniques laboratoriesmainly for occupational dosimetry assessment services Operates laboratories mainly for occupational dosimetry assessment and services (individual monitoring of the internal contamination, personal monitoring for external exposure, radon concentration) External Dosimetry Service Calibration Service Radon Service Internal Contamination Laboratories Photon Dosemeter Automatic packing and labeling machine for dosemeters Radon Dosemeter Body Counter Calibration Facility for radiotherapy instruments Skull phantom Calibration Facility for radiation protection instruments Project of Radon Dosemeter Lung counter

5. ENEA Radiation Protection Institute Bologna Secondary standard calibration laboratory - Secondary standard calibration laboratory (photon, beta and neutron) for radiation protection instruments and personal dosimetry Whole Body Counter - Whole Body Counter for monitoring the internal contamination (NaI(Tl)) external exposure - Personal dosimetry service for external exposure (TLD and track detectors) Radon - Radon concentration laboratory and service NORM laboratory - NORM laboratory aimed for dose assessment from radioactive aerosol inhalation numerical dosimetry - Computational facilities for numerical dosimetry Casaccia Individual monitoring laboratoriesinternal contaminationhigh- and low- energy Whole Body - Individual monitoring laboratories for the internal contamination: high- and low- energy Whole Body Counters (phoswich, NaI(Tl) and HPGe detectors), ICP-MS, LSC, alpha and gamma spectrometry Environmental surveillance - Environmental surveillance (alpha and beta counting, gamma spectrometry, Sr-90 and actinides determination) Radiobiology laboratories - Radiobiology laboratories (COMET-fish and microarrays techniques) Frascati - Laboratory for radon and tritium measurements in water - Gamma spectrometry and TLD measurements Saluggia and Trisaia Environmental surveillance - Environmental surveillance (alpha and beta counting, gamma spectrometry, Sr-90 and actinides determination) Radiobioassays for individual monitoring - Radiobioassays for individual monitoring of the internal contamination Whole Body Counter - Whole Body Counter for monitoring the internal contamination (NaI(Tl))

6. ENEA IRP is Voting member of EURADOS www.eurados.org E. Fantuzzi member of the Council (Vice Chiarman) Within EURADOS: Participation at European Working groups on research and harmonisation of radiation dosimetry CONRAD in FP6 EU-Trimer in FP7 : Technical Recommendation of Individual monitoring in external exposure (ENEA Tech. Ref. E. Fantuzzi) - DG TREN (total funding 187.000 euro, ENEA: 40.000)- Partners: GAEC+EURADOS ( RPII, HPA, ITN, PTB, NRG) EU Collaborations

7. ENETRAP FP6 - ENETRAP (01/04/06 -31/12/07) - ENEA Tech reference: A.Luciani SCK·CEN (B), Partners: BfS (D), CIEMAT (E), ENEA (I), FZK-FTU (D), HPA-RPD (UK), NSTN (F) NHC (UK), NRG (NL), SCK·CEN (B), UJF (F) Total Funding: € 400.000 (ENEA € 20.000) CONRAD CONRAD (01/01/05-31/03/08) - ENEA Tech reference: G. Gualdrini for WP4 Computational dosimetry (WP leader), A.Luciani, C.M. Castellani, P. Battisti for WP5 Internal exposures. ( => workshop !) ORAMED FP7 - ORAMED (under submission)- ENEA Tech reference: G. Gualdrini Partners: SCK-CEN (B), GAEC (EL), ENEA(I), IRSN(F), IRA(CH), UPC(ES), CEA(F), SMU(SK), NIOM(PL), BfS(D), RADCARD(PL), MGPI(F) Total costs: € 2.791.531, Funding: € 2.186.016 (ENEA share: € 209.200) TIARA2 TIARA2 (under submission)- ENEA Tech reference: A. Luciani Partners: CEA 4 (F), Hameln rds (D), CNRS (F), NRPA (N), STUK (F), CIEMAT (E), FZK (D), HPA (UK), KI (S), RIVM-NVIC (NL), FANC (B), GSF (D), ENEA (I), ASN (F), EQY (F) Total costs: € 3.411.973, Funding: € 2.750.833 (ENEA share: € 87.714) EU Projects

8. Objectives: to better integrate existing education and training activities in EU to develop more harmonised approaches for E&T in RP in EU and mutual recognitions of qualified experts Structure WP1: Implementation and co-ordination of ENETRAP WP2: Assessing the training needs and capabilities within the EU Member+ New Member and the Candidate States WP3: Recognition of competencies and diplomas WP4: On-the-Job Training (OJT) programmes WP5: New concepts and new tools for an ERPC WP6: IAEA E&T modules and European requirements WP7: Validation of the results and recommendations for a pilot course WP8: Establishment of a consortium of universities ENETRAP European Network on Education and Training in Radiological Protection

9. Objectives: Measurement and calculation of extremity and eye lens doses in interventional radiology Development of practical eye lens dosimetry in interventional radiology Optimisation of the use of active personal dosemeters in interventional radiology Improvements in extremity dosimetry in nuclear medicine, with special emphasis for PET applications and nuclear medicine therapy Knowledge dissemination and training Structure WP1:Extremity dosimetry and eye len dosimetry in interventional radiology/cardiology WP2: Development of practical eye lens dosimetry in interventional radiology (ENEA WP leader) WP3: Optimization of the use of active personal dosemeters in interventional radiology WP4: Extremity dosimetry in nuclear medicine WP5: Training and dissemination of results ORAMED Optimization of RAdiation Protection of MEDical Staff

10. Background Since 11 September 2001, the perception of risk for members of the public, linked to accidents or acts of terrorism and, in particular, the risk of deliberate release or dispersal of radionuclides has increased. => NEED FOR: A DECORPORATION TREATMENT to enhance elimination of internally deposited radionuclides compound may be administered in order to reduce the radiation dose. REASON WHY: Most of the treatments actually used were developed more than forty years ago. Experience of internal contamination has largely been gained in recent years from occupational exposure of workers. TIARA2 Treatment Initiatives After Radiological Accidents - part 2

11. Main objectives of this proposal are : the development of a DRY POWDER inhaler of DTPA for treating the contamination with radionuclides. The development will be performed up to the clinical ‘phase I’ study including human volunteers. the analysis of the present recommended treatments and the eventual gaps, for a list of radionuclides* of interest. the applied modelling of clinical data to improve the assessment of the efficacy of some treatments the proposition of some ways of harmonisation of treatment and protocols (decision of treatment, start and end of the treatment) between European states. the elaboration of ‘emergency treatment practical sheets’ for medical responders taking into account the advice or notice of the advisory board. Structure WP1: Management WP2: Preclinical pharmacokinetics and pharmacological efficacy of DTPA inhaler WP3: Pharmaceutical, toxicological and clinical studies of DTPA inhaler WP4: Applied modelling of human treatments WP5: Analysis of decorporation treatments, Harmonisation and Dissemination TIARA2 Treatment Initiatives After Radiological Accidents - part 2

12. Interventional radiology and cardiology require usually long X-ray exposure to the patient and to the medical staff. That can become particularly critical in case of infant and child procedures. Dose assessments are thus required both for radiation protection reasons and for the optimization of radiological procedures, following ALARA criteria. Analytical phantom can be proficiently used for numerical simulations accompanied by selected experimental tests (with tissue- equivalent or water filled phantoms) and an analysis of a series of medical procedures concerning time, radiological equipment set-up, number of projections, kVp and mAs. Medical staff and patient dosimetry

13. For their accuracy in human structures representation,voxel phantoms can be used as valuable tools for therapeutic treatment employing particles (neutrons and other hadrons). They can be used in the preliminary cost-benefits analysis and in the dosimetric assessment in all the stages of the treatment planning validation protocol. Voxel phantoms employed for dosimetry assessments in new therapies The ENEA Radiation Protection Institute is available, in collaboration with other Institutions and Hospitals, to employ and develop voxel phantoms for such new kinds of therapies. Currently an investigation is in progress at ENEA TAPIRO reactor for BNCT studies. A study on the undesirable patient dose for a typical BNCT treatment was studied and completed using numerical models.

14. As the internal dose, following an internal contamination, can not be directly measured but only inferred from data (urinary excretion, direct measurements of activity in organs or the whole body, etc.), biokinetic models need to be developed to represent the distribution and retention iof a radionuclide in the human body The Radiation Protection institute is engaged in : - implementing the models proposed by the International Commission on Radiological Protection - in developing and improving biokinetic models from radiobioassay data mainly obtained from: Cases of contamination of occupationally exposed workers Experiments on human volunteers Experiments on animals Internal Dosimetry Biokinetic models

15. Internal Dosimetry Biokinetic models Example of a compartmental models for Plutonium biokietics in humans after an intake via injection Methodologies used for the biokinetic modelling in the internal dosimetry may be applied in the medical field, particularly in all the therapeutic and diagnostic applications based on the use of not sealed radioactivity sources (e.g. Nuclear Medicine) Compartments : organs or tissues Arrows: Pu clearance rates Compartmental models are generally used in Radiation Protection Output of the model: - activity in the organs of interest - excretion rates - doses to the organs of interest

16. ENEA Health Project..just started ENEA has just approved and launched 18 main projects which convey under the same objective activities of more than one Department. Department for Biotechnologies, Agro-industry and Health Protection HEALTH Project The Department for Biotechnologies, Agro-industry and Health Protection is leading, among others, the “HEALTH Project” which coordinates all research activities in the field of Health developed by ENEA searching collaboration with Italian research institutes and Hospitals: - development of technologies for medical accelerators for proton therapy - radiobiology studies on radiation effects, damages at low doses, expecially for radiotherapy applications -development and experimental therapy with radio-pharmaceuticals for nuclear medicine applications -feasibility studies on BNCT with research reactors sited in ENEA Casaccia - radiation protection for staff and patients

17. ENEA expertise in biological dosimetry Molecular biology and radiobiology expertise since the 1960s Within the Department for Biotechnologies, Agro-industry and Health Protection, there is a long establised expertise since the 1960s in radiobiology and biological dosimetry, and this is one of the key knowledge on which the “ENEA Health project” is based: Evaluation of genetic damage induced by ionizing and non-ionizing radiation by using biomarkers of effect (e.g. CA, SCE, MN, comet assay) 2) Cytogenetic dosimetry for accidental (high dose) and occupational (low dose) radiation exposures for retrospective dose evaluation by using classic and molecular cytogenetic techniques (e.g. chromosomes painting) 3) Studies on individual susceptibility to ionizing radiation exposure. Evaluation of gene polymorphisms involved in DNA damage repair => Point 3 => Possible link with “Health” projects within 7FP to investigate either on cancerogenesis and individual susceptibility with studies on gene polymorphismsin radiotherapy => Point 3 => Possible link with “Health” projects within 7FP to investigate either on cancerogenesis and individual susceptibility with studies on gene polymorphisms in radiotherapy