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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - MEDIRAD (Implications of Medical Low Dose Radiation Exposure)

Teaser

Summary

MEDIRAD aims to enhance the scientific bases and clinical practice of radiation protection (RP) in the medical field and addresses the need to better understand and evaluate the health effects of low-dose ionising radiation (IR) exposure from diagnostic and therapeutic imaging and from off-target effects in radiotherapy (RT).
MEDIRAD pursues 3 major operational objectives:
â€¢ To improve organ dose estimation and registration to inform clinical practice, optimise doses, set recommendations and provide adequate dosimetry for clinical-epidemiological studies of effects resulting from exposures to IR in medicine;
â€¢ To evaluate and understand the effects of medical exposures, focusing on two major endpoints of public health relevance: cardiovascular effects of low to moderate doses of radiation from RT in breast cancer treatment including understanding of mechanisms, and long-term carcinogenic effects of low doses from CT in children;
â€¢ To develop science-based consensus recommendations for the effective protection of patients, workers and the general public.
To fulfil these, the 4-year MEDIRAD project relies on a multi-disciplinary consortium involving 33 partners from 14 European countries, a Scientific Advisory Board (with world-renowned experts in the fields of imaging, radiobiology, dosimetry, medical physics, epidemiology and ethics), a Stakeholder Board (with representatives from the medical associations EANM, EFOMP, EFRS, ESR and ESTRO, as well as the EURADOS, EURAMED and MELODI platforms on RP research, and the EPF), and a Stakeholder Forum (including health professionals, patients, nuclear scientists, policy-makers, competent authorities and representatives from international organisations).

Work performed

The first 18 months of the MEDIRAD project were mainly devoted to the development of working procedures and protocols, validations of tools, approval of the ethics where needed and setting up and starting the work foreseen in WPs 1-6.
WP1 (Project management and coordination): WP1 established the project governance and management procedures and organised several project meetings. Plans for communication and dissemination, quality assurance and risk management, and data management were prepared.
WP2 (Dose evaluation and optimisation in medical imaging): The clinical indications together with subjective criteria to assess image quality were established and a method for estimation of dose to primarily irradiated structures developed (Task 2.1). High-resolution chest CT image data sets on 18 individuals were acquired and segmentation started (Task 2.2). A survey on implementation and use of multi-modality imaging in nuclear medicine was conducted and data for Monte Carlo simulations were collected (Task 2.3). A prototype for a central DICOM repository was created (Task 2.4).
WP3 (Impact of low dose radiation exposure from I-131 radioiodine (NaI) ablation of thyroid cancer): Clinical data acquisition, site set-up and image processing protocols for dosimetry were developed and equipment calibrations were successfully carried out (Task 3.1). Work commenced for biokinetic modelling and treatment planning, including a literature review and development of a first model for the biodistribution of iodine in humans (Task 3.2). Dosimetry protocols were developed and a database set up (Task 3.3).
WP4 (Breast radiotherapy and secondary cardiovascular risks: establishing risk models for clinical support): The ethics approvals in the EARLY-HEART and BRACE studies were obtained and patient recruitment started (Task 4.1). Two experimental rodent models of whole heart irradiation were developed to investigate effects on the cardiovascular system (Task 4.2). A first mechanistic model was developed describing the key pathogenic processes of atherosclerosis. This model will incorporate mechanistic information obtained from the clinical and experimental studies (Task 4.3.)
WP5 (Possible health impact of paediatric scanning â€“ a molecular epidemiology study): Work in the case-control study of brain and haematological malignancies focused on the preparation of protocol, questionnaire, informed consent forms, procedures for contacting cases and controls and ethics approvals (Task 5.1). Tests were performed to select the most appropriate DNA and RNA saliva kits to analyse biological samples (Task 5.2), and the evaluation of the availability of additional scan data for the patients in the cohort has started (Task 5.3).
WP6 (Bringing together medical and nuclear scientific communities to improve patient and worker radiological protection across Europe): The Stakeholder Board (SHB) was set up and the chairman appointed. The workspace and user manual for the SHB and the Stakeholder Forum (SF) were set up. The process for the development of the recommendation documents has been drafted.

Final results

As the work to date involved the setting-up and approval of studies, the impact and implications are still limited.
MEDIRAD aims to achieve significant progress in the interaction between the RP and medical scientific communities at EU level, leading to cross-fertilisation of research efforts and provision of more consolidated and robust science-based policy recommendations to decision makers in both sectors. MEDIRAD was designed specifically, through consortium composition and choice of scientific goals, to illustrate the potential innovative results achievable through joint research efforts between these communities. It is the first time they work together on RP oriented objectives, thus considerably strengthen relations and interactions between them.
MEDIRADâ€™s long-term goal is to provide additional, improved practical measures for effective RP in the medical and nuclear sectors. Patient imaging and dose repositories will allow 1) much more precise understanding of diagnostic and therapeutic dose distributions in patients in different settings; 2) competent authorities to assess the pertinence of current policies, monitor evolution of medical doses, re-consider and refine the concept of Diagnostic Reference Levels and draw recommendations where necessary, particularly for sensitive populations. The repositories will be of particular relevance for the development of a â€œbig dataâ€ approach to low dose IR.
MEDIRAD will allow better evaluation of radiation risks and of necessary precautionary measures, leading to a more robust RP system for patients, workers and the general public, whilst not unduly penalising activities through unnecessary costly measures.
MEDIRAD has the potential to positively impact public IR risk perception and improve European research and innovation capacity and healthcare. Active stakeholder involvement in development of recommendations will enhance their capability to participate in Europe-wide dialogues about research planning, expressing relevant societal priorities/needs, which can be embedded in European research roadmaps and projects.
Industry opportunities will arise from MEDIRAD: innovative software for operational implementation of imaging repository; tools for image quality assessment and for optimisation; risk models, which could be imbedded in imaging or radiotherapy equipment software in healthcare institutions.