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Comparative Evaluation of Therapeutic Radiopharmaceuticals by International Atomic Energy Agency

By International Atomic Energy Agency

STI/DOC/010/4458.

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Specific objectives of the CRP included: — Development of methods for labelling, purification and quality control of therapeutic radiopharmaceuticals for neuroendocrine tumours based on different carrier molecules and radionuclides; — Standardization of in vitro methods for comparative evaluation of radiopharmaceuticals for biological integrity, cell binding, serum stability, kinetics, internalization and cytotoxicity; — Establishment of in vivo models for comparative evaluation of biodistribution, in vivo stability and therapeutic efficacy.

Reversed phase extraction was carried out by preconditioning the cartridges with 5 mL of ethanol (70%) and subsequently activating them with 5 mL of 2-propanol and 5 mL of distilled water. 11]. The solvent was evaporated under a gentle stream of nitrogen, and the dry residue was dissolved in 2–5 mL of PBS or saline. To determine the radiolabelling yield, the radioactivities in the fractions eluted from the SepPak C18 cartridges and the SepPak cartridges themselves were measured in a dose calibrator (Capintec) under similar geometric conditions.

Dose–response curve for the percentage of binucleated cells (BNC) with micronuclei (MN) after 1 h of exposure of human peripheral lymphocytes to different radioactive concentrations of (a) [131I]DOTATATE and (b) [177Lu]DOTATATE. and the radioactive concentrations of radiopharmaceuticals (X) labelled with I (Fig. 12(a)) and with 177Lu (Fig. 12(b)). 8563) for [177Lu]DOTATATE. Apparently, both types of radiopharmaceutical induced similar chromosomal alterations at the cytogenetic level. 53 for the cells exposed to either [131I]DOTATATE or [177Lu]DOTATATE.

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