[Safety, biodistribution, and dosimetry of myocardial imaging agent 99Tc(m)N-NOET in healthy volunteers].
OBJECTIVE
To study the safety, biodistribution, and dosimetry of myocardial perfusion imaging agent 99Tc(m)N-NOET in 10 healthy volunteers.


METHODS
744-792 MBq of 99Tc(m)N-NOET was injected to each volunteer. Safety parameters and adverse event was measured in 24 hours of injection. Biodistribution was studied by whole-body imaging 1, 30 minutes, 1, 2, 4, 8, and 24 hours after the injection of 99Tc(m)N-NOET. The estimation of dosimetry was based on the standard medical internal radiation dose method using MIRDOSE 3.0 analysis program. Myocardial single photon emission computed tomography (SPECT) imaging was performed at 1 and 4 hours after injection.


RESULTS
No undesirable effects were reported by the subject during 24 hours after injection of 99Tc(m)N-NOET. No clinically significant changes were found in vital signs (heart rate, blood pressure, and electrocardiogram). No biochemical aspects and serology changes were measured. The myocardial SPECT imaging was clear. Cardiac uptake of 99Tc(m)N-NOET was as high as 2.68% at 2 hours after injection. The heart to lung ratio was more than 1 from 30 minutes after injection, reaching a maximum of 1.91 +/- 0.53 at 2 hours after injection. Radiation dosimetry calculations indicated an effective absorbed dose of 1.28 x 10(-5) Sv/MBq. The dosimetry in each main organ is lower then 50 mGy given 740 MBq of 99Tc(m)N-NOET in once imaging.


CONCLUSIONS
99Tc(m)N-NOET exhibits high cardiac uptake and low estimated effective absorbed dose. It's a safe myocardial perfusion imaging agent.
Du
Yan-rong
YR
Department of Nuclear Medicine, PUMC Hospital, CAMS and PUMC, Beijing 100730, China.
Li
Fang
F
Wang
Xue-bin
XB
Tang
Zhi-gang
ZG
Tian
Jian
J
Ba
Jian-tao
JT
Long
Ming-qing
MQ
Zhang
Jun-bo
JB
D006321:Heart / Q000000981:diagnostic imaging*; D006801:Humans; D009206:Myocardium / Q000378:metabolism; D015609:Organotechnetium Compounds / Q000009:adverse effects / Q000493:pharmacokinetics*; D011829:Radiation Dosage; D019275:Radiopharmaceuticals / Q000009:adverse effects / Q000493:pharmacokinetics*; D013859:Thiocarbamates / Q000009:adverse effects / Q000493:pharmacokinetics*; D014018:Tissue Distribution; D015899:Tomography, Emission-Computed, Single-Photon
D015609:Organotechnetium Compounds; D019275:Radiopharmaceuticals; D013859:Thiocarbamates; C093922:technetium Tc 99m, bis(N-ethoxy-N-ethyldithiocarbamato)nitrido-