Establishing traceability routes in nuclear medicine

Over 9 million patients receive injections of radiopharmaceuticals each year across Europe, either for diagnostic purposes or as treatments in areas covering oncology, neurology and cardiology. 

The EU directive 2013/59/EURATOM, for basic safety standards on protection against ionising radiation, states that all absorbed radiation doses should be calculated in a traceable manner. However, accuracy in the measurement of intended activity injected to patients can be 10 % or more from the prescribed value. This leads to both variability in the diagnostic images produced and in the accuracy of absorbed doses delivered to tumours. A main reason is that over 20 radionuclides are used for diagnosis and therapy, and each requires traceability to its own primary standard. As not all National Metrology Institutes (NMIs) or Designated Institutes (DIs) maintain these primary standards direct access to calibration services is not always possible despite the legal requirements and patient benefits.

This project will provide traceability routes and calibration services for key radionuclides with an uncertainty of 2 % or better, developed in collaboration with the local responsible NMI/DI and partner hospitals. It will also validate the effectiveness of these by performing comparison exercises, targeting that 80% or more of participants are from emerging metrology in this field. Guidance documents will also be developed to further improve the accessibility of traceable calibration routes in Europe.

This will ensure clinics and hospitals will be able to comply to European directives and provide a better outcome for the millions of patients treated each year with radionuclides.