Biodistribution, Safety Profile, and Radiation Dosimetry of [<sup>18</sup>F]SYN2, a PET Cardiac Perfusion Tracer, in Healthy Subjects
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, [<sup>18</sup>F]SYN2 (<sup>18</sup>F-labeled acridine derivative), in healthy subjects. <b>Methods:</b> [<sup>18</sup>F]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. <b>Results:</b> 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/m<sup>2</sup> 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 [<sup>18</sup>F]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. <b>Conclusion:</b> On the basis of the safety profile, radiation dosimetry, and biodistribution of [<sup>18</sup>F]SYN2, it appears to be a promising agent for clinical PET myocardial perfusion imaging and to warrant further clinical studies.
Authors
- Leszek Królicki (ORCID: https://orcid.org/0000-0002-7117-9621)
- Seweryn Krajewski (ORCID: https://orcid.org/0009-0006-4048-9842)
- Jacek Bil (ORCID: https://orcid.org/0000-0002-8724-5611)
- Mouaz Husayn Al-Mallah (ORCID: https://orcid.org/0000-0003-2348-0484)
- Łukasz Steczek
- Panithaya Chareonthaitawee (ORCID: https://orcid.org/0000-0002-3811-8712)
- Małgorzata Kobylecka (ORCID: https://orcid.org/0000-0002-3491-6514)
- Tuula Tolvanen (ORCID: https://orcid.org/0000-0002-3308-1260)
- Mirosław Dziuk
- Magdalena Kostkiewicz (ORCID: https://orcid.org/0000-0001-9094-3202)
- Cezary Kozanecki
- Juhani Knuuti (ORCID: https://orcid.org/0000-0003-3156-9593)
- Kari K. Kalliokoski (ORCID: https://orcid.org/0000-0002-8893-7126)
- Prem Soman (ORCID: https://orcid.org/0000-0003-1425-6536)
- Piotr J. Slomka (ORCID: https://orcid.org/0000-0002-6110-938X)
- Joanna Włostowska
- Joanna Towpik
- Przemysław Kozanecki
- Karina Gotowicz
- Timothy M. Bateman (ORCID: https://orcid.org/0009-0007-7959-6159)
Institutions
- Centrum Badań Kosmicznych (PL)
- Jagiellonian University (PL)
- National Academy of Medicine (US)
- Cedars-Sinai Medical Center (US)
- Synlab Czech (Czechia) (CZ)
- Houston Methodist (US)
- Mayo Clinic (US)
- Saint Luke's Health System (US)
- Medical University of Warsaw (PL)
- Turku University Hospital (FI)
- John Paul II Hospital (PL)
- Turku PET Centre (FI)
- Ministry of Interior and Administration (PL)
- University of Pittsburgh Medical Center (US)
- Institute of Cardiology (PL)
- University of Warsaw (PL)
Publication Details
- Journal
- Journal of Nuclear Medicine
- Published
- 2025-03-06
- DOI
- https://doi.org/10.2967/jnumed.124.268872
- Citations
- 3
- Primary Topic
- Cardiac Imaging and Diagnostics
- Type
- article
- Field-Weighted Citation Impact
- 4.08