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Preclinical acute toxicity, biodistribution, pharmacokinetics, radiation dosimetry and microPET imaging studies of [(18)F]fluorocholine in mice.
Silveira, Marina B; Ferreira, Soraya M Z M D; Nascimento, Leonardo T C; Costa, Flávia M; Mendes, Bruno M; Ferreira, Andrea V; Malamut, Carlos; Silva, Juliana B; Mamede, Marcelo.
Appl Radiat Isot ; 116: 92-101, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27509594

ABSTRACT

[(18)F]Fluorocholine ([(18)F]FCH) has been proven to be effective in prostate cancer. Since [(18)F]FCH is classified as a new radiopharmaceutical in Brazil, preclinical safety and efficacy data are required to support clinical trials and to obtain its approval. The aim of this work was to perform acute toxicity, biodistribution, pharmacokinetics, radiation dosimetry and microPET imaging studies of [(18)F]FCH. The results could support its use in nuclear medicine as an important piece of work for regulatory in Brazil.


Subject(s)
Choline/analogs & derivatives , Positron-Emission Tomography/methods , Prostatic Neoplasms/diagnostic imaging , Prostatic Neoplasms/metabolism , Radiation Injuries/etiology , Whole-Body Counting , Absorption, Radiation , Animals , Choline/pharmacokinetics , Choline/toxicity , Drug Evaluation, Preclinical , Humans , Male , Metabolic Clearance Rate , Mice , Mice, Inbred C57BL , Organ Specificity , Radiation Injuries/diagnosis , Radiopharmaceuticals/pharmacokinetics , Radiopharmaceuticals/toxicity , Reproducibility of Results , Sensitivity and Specificity , Tissue Distribution , Toxicity Tests , Whole Body Imaging/methods
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