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- W10243855 abstract "1432 Objectives LMI1195, a novel 18F ligand for the norepinephrine transporter (NET) is in clinical development as for mapping the cardiac nerve terminal in vivo using positron emission tomography. Human safety, whole-organ biodistribution and radiation dosimetry of LMI1195 were evaluated in a Phase I clinical trial. Methods 12 normal subjects were injected IV with 150-250 MBq of LMI1195. Dynamic PET images were obtained over the heart for 10 minutes, followed by sequential whole body images for approximately 5 hours. Blood samples were obtained and heart rate, ECG and blood pressure were monitored prior to and during imaging. Residence times were determined from multi-exponential regression of organ ROI data normalized by injected dose. Radiation dose estimates were calculated using OLINDA/EXM. Myocardial (M), lung, liver (LI), and blood pool SUV’s were determined at different time intervals. Results No adverse events due to LMI1195 were seen. The four highest-dose organs and their respective mean dose estimates were urinary bladder wall, 3.5-hr void (0.10 ± 0.020 mSv/MBq), kidneys (0.083 ± 0.014 mSv/MBq), thyroid (0.066 ± 0.011 mSv/MBq) and small intestine (0.046 ± 0.008 mSv/MBq). Mean effective dose was 0.026 ± 0.0012 mSv/MBq. Approximately 1.6% of the injected dose (ID) was seen in the myocardium initially, remaining above 1.5% of ID (decay-corrected) through 4 hours after injection. M/LI was approximately equal initially increasing to more than 2 at 4 hours. Blood radioactivity cleared quickly and lung activity was low throughout the study. Conclusions These early data suggest that LMI1195 is well tolerated and yields a radiation dose comparable to that of other commonly-used PET radiopharmaceuticals. Myocardial uptake and adjacent organ activity suggest that good images should be possible with acceptable patient radiation dose" @default.
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- W10243855 date "2010-05-01" @default.
- W10243855 modified "2023-09-26" @default.
- W10243855 title "Radiation dosimetry of LMI1195, first-in-human study of a novel F-18 labeled tracer for imaging myocardial innervation" @default.
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