Toxicity studies in Sprague-Dawley rats and radiation dosimetry studies in Formosa Rock monkeys suggested that 4-[(18)F]-ADAM is safe for use in human PET imaging studies.

Background[18 F]AFM is a potent and promising PET imaging agent for the serotonin transporter. We carried out an acute toxicity study in rats and radiation dosimetry in monkeys before the translation of the tracer to humans.MethodsSingle- and multiple-dose toxicity studies were conducted in Sprague–Dawley rats. Male and female rats were injected intravenously with AFM tartrate as a single dose of 98.7 or 987 μg/kg (592 or 5,920 μg/m2, 100× or 1,000× the proposed human dose of 8 μg, respectively) on day 1 or as five consecutive daily doses of 98.7 μg/kg/day (592 μg /m2/day, 100× human dose, total dose 493.5 μg/kg). PET/CT scans were performed in four Formosan rock monkeys (two males and two females, each monkey scanned twice) using a Siemens BIOGRAPH scanner. After injection of [18 F]AFM (88.5 ± 20.3 MBq), a low-dose CT scan and a series of eight whole-body PET scans in 3-D mode were performed. Time-activity data of source organs were used to calculate the residence times and estimate the absorbed radiation dose using the OLINDA/EXM software.ResultsIn the rats, neither the single dose nor the five daily doses of AFM tartrate produced overt adverse effects clinically. In the monkeys, the radiation doses received by most organs ranged between 8.3 and 39.1 μGy/MBq. The osteogenic cells, red marrow, and lungs received the highest doses of 39.1, 35.4, and 35.1 μGy/MBq, respectively. The effective doses extrapolated to male and female adult humans were 18.0 and 18.3 μSv/MBq, respectively.ConclusionsToxicity studies in Sprague–Dawley rats and radiation dosimetry studies in Formosa rock monkeys suggest that [18 F]AFM is safe for use in human PET imaging studies.Trial registrationIACUC-12-200.

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Abstract To investigate the possible influence of head rotation on the results of salivary gland scintigraphy, a phantom study was designed to simulate clinical salivary gland scintigraphy. The quantitative accuracy of regional activity counts was compared for two data acquisition methods involving head rotation: (i) an anterior planar projection-only (ANT) method and (ii) a geometric mean (GM) method using both the anterior and posterior planar projections. The roles and limitations of the GM and ANT methods when used at different head rotation angles were examined. Parallel planar projections of a head phantom with four salivary gland simulators, containing 3.7 MBq 99mTc-sodium pertechnetate, at various rotational settings were acquired using a dual-head gamma camera. The difference between the standard activity counts (no phantom rotation) and the activity counts affected by the phantom rotation was calculated and defined as the rotational bias that decreased the accuracy of activity quantification. For small-angle rotation (≤10°), use of the GM method decreased the bias for all salivary gland simulators. In contrast, the bias of large-angle rotation (>10°) between four salivary gland simulators became conspicuous and complex in both methods. This bias may reflect different attenuation effects caused by displacement of the structures. Our data suggest that the GM method can be used when the head rotation angle is small (≤10°); however, when the head rotation angle is >10°, the non-negligible influence of head rotation should be considered during image acquisition.

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