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Incorporation dosimetry of F-18-Flubatine – Comparison of animal model data with first-in-man results
Sattler, B.; Kranz, M.; Patt, M.; Donat, C.; Deuther-Conrad, W.; Hoepping, A.; Sattler, T.; Brust, P.; Steinbach, J.; Sabri, O.;
Objectives: (-HF-18]-Flubatine (former NCFHEB) is a new tracer for neuroimaging of !l4ß2 nAChRs with PET. To assess the radiation risk, its biodistribution, organ doses (00) and effective dose (EO) were determined in pigs and compared to earlier results in mice and humans [SNM20J J No. 1454, 1459J.
Methods: For whole body dosimetry, 5 female piglets (age: 44±3.0d, weight: 13.7±1.7kg) were narcotized (20 mglkg Ketamine, 2mglkg Azaperone; 1.5% Isoflurane in 70% N20/30% 02) and sequentially imaged up to 5h post i.v. injection of 186.6±7.4MBq F1ubatine on a PET/CT-system with 7 bed positions (BP) per frame, J .5-6min/BP, CT-attenuation correction and iterative reconstruction. All relevant organs were defined by volumes of interest. Exponential curves were fitted to the time-activitydata (%ID/g, and %IO/organ). Time and mass were adapted to the human scale. The OOs were calculated using the adult male model with OLINOA. The EO was calculated using tissue weighting factors as published in the ICRPI03.
Results: The highest 00 was received by the urinary bladder (49.0± 19.4j.1SvIMBq*) and the kidneys (39.9±6. J *). The highest contribution to the EO was by the urinary bladder (2.0±0.7*) and the stornach (1.5±0.3*). The EO to humans after i.v. injection of(-)-Flubatine is 14.6±3.2*.
Conclusions: As true for other PET-Tracers, preclinical dosimetry potentially underestimates the EO to humans. The EO by F1ubatine yielded from pig-(this study) and mice-(14.2j.1SvIMBq) studies compared to human dosimetry (22.6±0.68j.1Sv/MBq) show that animal dosimetry underestimates the potential radiation exposure to humans by 35-37%. This fact needs to be considered in the assessment ofthe EO to humans prior early phase clinical trials.
Research Support: The study was supported by Strahlenschutzseminar in Thüringen e. V
  • Abstract in refereed journal
    Journal of Nuclear Medicine 53(2012)1, 1503

Publ.-Id: 18157 - Permalink