RT Journal Article
SR Electronic
T1 Biodistribution, Safety Profile, and Radiation Dosimetry of [<sup>18</sup>F]SYN2, a PET Cardiac Perfusion Tracer, in Healthy Subjects
JF Journal of Nuclear Medicine
JO J Nucl Med
FD Society of Nuclear Medicine
SP 626
OP 633
DO 10.2967/jnumed.124.268872
VO 66
IS 4
A1 Knuuti, Juhani
A1 Kobylecka, Małgorzata
A1 Krajewski, Seweryn
A1 Steczek, Lukasz
A1 Gotowicz, Karina
A1 Towpik, Joanna
A1 Kalliokoski, Kari
A1 Tolvanen, Tuula
A1 Kostkiewicz, Magdalena
A1 Kozanecki, Przemysław
A1 Włostowska, Joanna
A1 Dziuk, Mirosław
A1 Królicki, Leszek
A1 Bil, Jacek
A1 Slomka, Piotr J.
A1 Bateman, Timothy M.
A1 Al-Mallah, Mouaz H.
A1 Chareonthaitawee, Panithaya
A1 Soman, Prem
A1 Kozanecki, Cezary
YR 2025
UL http://jnm.snmjournals.org/content/66/4/626.abstract
AB A first-in-human phase I clinical study aimed to assess the safety profile, radiation dosimetry, and biodistribution of a potential cardiac PET myocardial perfusion imaging tracer, [18F]SYN2 (18F-labeled acridine derivative), in healthy subjects. Methods: [18F]SYN2 intravenous administration with PET imaging was performed on healthy volunteers, and sequential whole-body imaging was performed over 4 h. Blood and urine samples were collected for up to 240 min. Safety follow-up visits took place at 2, 5, and 14 d after the administration. Results: Ten subjects (8 women and 2 men) completed all study procedures. The mean age was 38.1 ± 8.8 y, and the mean body mass index was 22.7 ± 3.0 kg/m2. The mean administered dose of radioactivity was 258 MBq (range, 246–272 MBq). There were no drug-related adverse events, and the tracer was well tolerated in all subjects. The mean whole-body effective radiation dose for [18F]SYN2 was 0.0195 mSv/MBq. The tracer was rapidly taken up by the myocardial wall and cleared from plasma, leading to good image quality within minutes of tracer injection. Conclusion: On the basis of the safety profile, radiation dosimetry, and biodistribution of [18F]SYN2, it appears to be a promising agent for clinical PET myocardial perfusion imaging and to warrant further clinical studies.