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Clinical Trial
. 2025 Apr 1;66(4):626-633.
doi: 10.2967/jnumed.124.268872.

Biodistribution, Safety Profile, and Radiation Dosimetry of [18F]SYN2, a PET Cardiac Perfusion Tracer, in Healthy Subjects

Juhani Knuuti  1   2 , Małgorzata Kobylecka  3 , Seweryn Krajewski  4 , Lukasz Steczek  5 , Karina Gotowicz  5   6 , Joanna Towpik  5 , Kari Kalliokoski  1 , Tuula Tolvanen  1 , Magdalena Kostkiewicz  7   8 , Przemysław Kozanecki  5 , Joanna Włostowska  5 , Mirosław Dziuk  9   10 , Leszek Królicki  3 , Jacek Bil  11 , Piotr J Slomka  12 , Timothy M Bateman  13 , Mouaz H Al-Mallah  14 , Panithaya Chareonthaitawee  15 , Prem Soman  16 , Cezary Kozanecki  5
Affiliations
Clinical Trial

Biodistribution, Safety Profile, and Radiation Dosimetry of [18F]SYN2, a PET Cardiac Perfusion Tracer, in Healthy Subjects

Juhani Knuuti et al. J Nucl Med. .

Abstract

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.

Keywords: MPI; PET imaging; [18F]SYN2; [18F]tracer; cardiac imaging; phase I clinical study.

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References

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