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Basics and Principles of Radiopharmaceuticals for PET/CT

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Basics and Principles of Radiopharmaceuticals for PET/CT European Journal of Radiology 73 (2010) 461–469 Contents lists available at ScienceDirect European Journal of Radiology journal homepage: www.elsevier.com/locate/ejrad Review Basics and principles of radiopharmaceuticals for PET/CT W. Wadsak a, M. Mitterhauser a,b,∗ a Department of Nuclear Medicine, Medical University of Vienna, Austria b Department of Pharmaceutical Technology and Biopharmaceutics, University of Vienna, Austria article info abstract Article history: The presented review provides general background on PET radiopharmaceuticals for oncological appli- Received 1 December 2009 cations. Special emphasis is put on radiopharmacological, radiochemical and regulatory aspects. This Accepted 15 December 2009 review is not meant to give details on all different PET tracers in depth but to provide insights into the general principles coming along with their preparation and use. Keywords: The PET tracer plays a pivotal role because it provides the basis both for image quality and clinical Radiopharmaceutical interpretation. It is composed of the radionuclide (signaller) and the molecular vehicle which determines Tracer the (bio-)chemical properties (e.g. binding characteristics, metabolism, elimination rate). Radiopharmacology Radiochemistry © 2010 Published by Elsevier Ireland Ltd. This section is intended to provide general background on PET resulting in abnormal function it can probably be visualized long radiopharmaceuticals for oncological application. Special empha- before morphological manifestation. sis is put on radiopharmacological, radiochemical and regulatory Basically, there are three major disciplines that have to inter- aspects. This review is not meant to give details on all different PET act and collaborate closely to enable the successful application of tracers in depth but to provide insights into the general principles PET/CT in a clinical setting: medical physics, radiopharmaceuti- coming along with their preparation and use. cal sciences and clinical imaging (see Fig. 1). The protagonists of these disciplines – each covering its specific field in depth – have 1. The role of radiopharmaceuticals in PET/CT to understand the basic principles and comprehend the different scientific language. Hence, understanding of radiopharmaceutical Radiopharmaceuticals, already attributed to as drugs in 1960 issues is pivotal to understanding imaging on a molecular level! [1], are radiolabelled molecules designed for in vivo application. The PET tracer plays a central role because it provides the basis These radiopharmaceuticals consist of two parts: (1) a molecular both for image quality and clinical interpretation. The radionuclide structure determining the fate of the radiopharmaceutical within with its specific physical properties is the working basis for sig- the organism (pharmacokinetics and pharmacodynamics) and (2) a nal detection, transduction and computational translation. On the radioactive nuclide being responsible for a signal detectable outside other hand, understanding the (bio-) chemical properties of the of the organism for subsequent visualization with nuclear medi- molecular vehicle (e.g. binding characteristics, metabolism, elim- cal methods. Since these imaging methods are directly based on ination rate) is essential for molecular modelling and dosimetry. radiolabelled molecules they can truly be called “molecular imaging” From a clinical point of view, basic understanding of radiochemical modalities. preparation (e.g. formation of potential by-products, interference Since radiopharmaceuticals are chemically indistinguishable of labelled and unlabelled contaminants with the target site, spe- from their non-radioactive counterparts the organism does not cific radioactivity) is also necessary for diagnosis using PET/CT. make a difference in using the radiolabelled derivatives as surro- Radiopharmaceuticals are a very rare and special species. And gates in all its biochemical processes. Thus, radiopharmaceuticals radiopharmacists (and medical radiochemists) are also a rare can be used to directly visualize these functional processes in vivo. species within their disciplines. But it needs these specially trained If, for example, there is a pathological change on the molecular level experts to guarantee continuous availability and safety of these special pharmaceuticals. Medical radiochemistry and radiophar- macy were – and still are – treated as orchid areas within their ∗ scientific home faculties; it needs special interest and freakish Corresponding author at: Waehringer Guertel 18-20, A-1090 Vienna, Austria. dedication in the preparation of drugs on a sub-nanomolar scale. Tel.: +43 1 40400 1557; fax: +43 1 40400 1559. E-mail address: [email protected] (M. Mitterhauser). However, during the last decades a lot of emphasis has been put URL: http://www.radiopharmaceutical-sciences.net (M. Mitterhauser). into the establishment of a certified education and its recognition in 0720-048X/$ – see front matter © 2010 Published by Elsevier Ireland Ltd. doi:10.1016/j.ejrad.2009.12.022 462 W. Wadsak, M. Mitterhauser / European Journal of Radiology 73 (2010) 461–469 Table 1 Important PET nuclides and their most common ways of preparation. Nuclide Production Half-life F-18 (F−) 18O(p,n)18F 110 min 20 18 F-18 (F2) Ne(d,␣) F 110 min C-11 14N(p,␣)11C 20 min N-13 16O(p,␣)13N 10 min O-15 14N(d,n)15O 2 min Ga-68 68Ge/68Ga-Generator 68 min Rb-82 82Sr/82Rb-Generator 1.3 min The vehicle molecules either interact directly with the afore- mentioned targets and processes – they can be substrates for enzymes, agonists or antagonists for receptors and transporters – or take part directly in metabolic processes. In a pathophysiological state, these targets and/or processes Fig. 1. Schematic illustration of the interaction of the three major disciplines may be changed significantly compared to their normal state and involved in PET/CT, highlighting the central role of the PET tracer. functionality. Therefore, interaction of the vehicle molecules may also be changed considerably. For example, in many tumours the Europe. Thus, nowadays “certified freaks” are available to perform expression rate of receptors, transporters, enzymes and antigens all kinds of radiopharmaceutical tasks in routine and R&D. is modified and these alterations may serve as a suitable predictor for stage and allocation of these tumours. To achieve a personal- 2. What is a PET radiopharmaceutical ized diagnosis from outside the body without invasive intervention, suitable interactions between vehicle and target site alone are not Principally, a PET radiopharmaceutical consists of two compo- enough. It needs for an additional signaller stably attached to the nents (see Fig. 2): vehicle. Thus, traceability of the pharmaceutical’s fate and pathway is guaranteed. (1) A molecular structure (vector, vehicle, ligand) and (2) a positron emitting radionuclide. 2.2. PET radionuclides For a stable connection of these two parts, a linker may be chem- For PET, these signallers attached to the vehicle molecules are ically necessary. The vehicle defines the biological characteristics positron emitting nuclides. The most important PET nuclides are and is responsible for chemical and biochemical interactions within summarized in Table 1. the living organism. The positron emitting radionuclide provides a All widely used PET nuclides are short lived with limited avail- detectable signal enabling coincidence measurements of annihi- ability. On the other hand, wide and feasible availability of the lation radiation within a dedicated PET device such as a PET/CT radionuclide is a prerequisite for successful application on a routine scanner. basis. Therefore, only fluorine-18 and gallium-68 are used in a clin- ical setting in PET sites without on-site cyclotron, so far. On the one 2.1. Vehicle molecules hand, registered F-18 labelled radiopharmaceuticals are distributed by commercial vendors and can be used directly. On the other hand, The vehicle molecules have to provide a high degree of speci- gallium-68 generators can be simply installed locally and their easy ficity and selectivity towards the target site. These targets can be handling does not require specific technical equipment. Concerning e.g.: the other PET nuclides, generally, the production has to be per- formed in a medical cyclotron on-site. This demands for dedicated • selected receptor systems, equipment and specially trained and qualified personnel. • antigens, Possible ways of use are different for different types of radionu- • enzymes, clides. As examples, Fig. 3 illustrates the main pathways of • transporters, radiochemical conversions for fluorine-18 and carbon-11. • specific metabolic alterations, The selection of the PET radionuclide has to be based on the • such as up-regulated conditions, following considerations: • hypo-oxygenation of tissue, • different energy demand of cells, (1) Availability of the radionuclide; • changes in gene and protein expression, (2) physical characteristics of the radionuclide; • differences in vascularisation and perfusion. (3) radiochemical issues; (4) radiopharmacological issues. Besides the issues already discussed above, even in PET centres with on-site production facility, the very short half-life of radionu- clides such as oxygen-15 (2 min) and nitrogen-13 (10 min) limits their clinical applicability. Therefore, only a handful PET-centres worldwide is using these radionuclides on a daily routine basis. Overall, the half-life of the radionuclide should be long enough
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