ABSTRACT

Recent developments in medical imaging with, for example, PET and SPECT systems have expanded the available agents beyond those based on just 99m-Tc or 18-F to include longer-lived radionuclides, such as, 64-Cu, 68-Ga, 89-Zr, and 124-I suited to particular targeting molecules. Advances in scanners and image reconstruction techniques have made it possible for these modalities to be quantitative. In therapeutic nuclear medicine, radionuclides, such as 67-Cu, 90-Y, 166-Ho, and 177-Lu, are being developed for an ever-expanding array of applications. Radionuclides that emit beta-particles take advantage of the ability of electrons to deliver a high dose to diseased tissue while sparing nearby healthy tissue. Also, new radiopharmaceuticals incorporating alpha-emitting radionuclides take advantage of the high linear energy transfer of alpha particles to more precisely target diseased tissues. The safety and effectiveness of any nuclear medicine procedure is highly dependent on the accuracy of the measurement of radioactivity in the injected radiopharmaceutical. The use of radioactivity standards and properly calibrated measurement equipment in the context of a well-developed quality management system (QMS) can help ensure the accuracy and dependability of those measurements. Traceability is defined as the ‘property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty’. Implicit in this definition is the existence of a reference or standard against which a measurement can be compared or calibrated. This chapter deals with the practical application of the concepts of traceability, calibration, and quality assurance.