In addition, minimum contaminated waste materials remain. 14Ĭonsequently, preparation as well as quality control of a licensed kit require at least the equipment according to the instructions provided by the manufacturer. If the instructions for use are not strictly followed or if one or more components used for the preparation do not have marketing authorization, it is the responsibility of the radiopharmacy to demonstrate that the quality of the final preparation is suitable for the intended use. As stated by the European Pharmacopoeia (Ph Eur) in general chapter “Extemporaneous Preparation of Radiopharmaceuticals” is the marketing authorization holder of a licensed kit responsible to ensure that the kit complies with the requirements of its marketing authorization, while the radiopharmacy using that licensed kit carries the responsibility for the quality of the preparation and the handling. The radiolabelling kits should make the production of 68Ga radiopharmaceuticals as easy as the production of 99mTc-radiopharmaceuticals. Both concepts should guarantee an easy, safe, and reliable production of 68Ga radiopharmaceuticals with stable high yields and pharmacopoeia compliant product quality. To avoid these problems in clinical routine, two general concepts were established: using (a) synthesis modules and most recently (b) radiolabelling single vial cold kits.
NETSPOT KIT MANUAL
The two main problems are the radiation dose to the operator to and potential variability within production.Įxample setup of a manual 68Ga-radiolabelling for clinical practice In many cases, preparation of 68Ga radiopharmaceuticals is still manual (Figure 1), although this method would not be adequate for routine clinical applications. One of the critical factors in clinical practice is the production of a radiopharmaceutical. Both compounds, PSMA-11 and PSMA-617 are now well established in clinical practice. From those potent agents, the DOTA derivative PSMA-617 emerged as a powerful theranostic tool for PC.
NETSPOT KIT PC
As low-molecular-weight compounds presented very promising properties as PC imaging agents, 10- 13 urea-based peptidomimetic inhibitors with a high affinity to PSMA were developed. 9 Due to the low expression of PSMA in healthy tissue, with the exception of salivary and lacrimal glands, high-dose radioligand therapy is possible. 7, 8 Its extracellular N-terminal part, containing the catalytic domain, is suitable for selective tumour targeting. 6 Prostate-specific membrane antigen (PSMA) is a transmembrane molecule in prostate tissue and highly overexpressed in PC. PC is one of the most common causes of cancer-related mortality in western societies. With the introduction of PSMA-11 and PSMA-617 for prostate cancer (PC) theranostics, 4, 5 a second boom of the still exotic PET radionuclide gallium-68 started. This so-called theranostic approach, nowadays, well established with gallium-68/lutetium-177 as diagnostic/therapeutic pair, initiated the growing interest in radiometals for clinical application beyond technetium-99m. 3 DOTA as chelator makes it possible to apply the same molecule for diagnosis and therapy simply by the choice of radionuclide. 2 Rapid accumulation in neoplastic tissue and fast clearance from healthy organs enables the delivery of a high dose of radiation on the target site and thus preserves the surrounding healthy tissue. The rise of gallium-68 started with the development of somatostatin analogue edotreotide (DOTA-TOC), which targets tumours overexpressing somatostatin receptors. Its radiolabelling potential with cyclic conjugates and its short half-life (T 1/2 = 67.71 min) qualifies it for PET imaging with probes of short biological half-life.
Gallium-68 is available from a 68Ge/ 68Ga-generator because of its convenient nuclear properties. In recent years, the application of 68Ga radiopharmaceuticals has increased for positron emission tomography (PET) imaging in research as well as in clinical practice.
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