Date: 08 Dec 2011

Suggested pathway to assess radiation safety of 11C-labeled PET tracers for first-in-human studies

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Dear Sir,

Before a new radioactive tracer can be used in humans, many national as well as local Institutional Radiation Safety Committees often require that a biodistribution study be conducted in animals. The aim of these time-consuming and expensive studies is to assess the dose of absorbed radiation in animals so that the human dose can be extrapolated. Because of their physical similarity to humans (organ size and body weight), monkeys are arguably the best animal species to estimate radiation burden in human subjects. The extrapolation can be performed with different methods [1], for example by converting the percent administered activity in the monkey organ to percent administered activity in the same human organ. Basically, the human residence time for a given organ is derived by performing the animal to human organ mass ratio multiplication for each time point and then by integrating that time-activity curve to derive a hypothetical area under the curve for that human organ. Thi ...