Biodistribution, Safety Profile, and Radiation Dosimetry of [18F]SYN2, a PET Cardiac Perfusion Tracer, in Healthy Subjects
Year: 2025
Type: article
Study design: Clinical Trial
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.
Source: Journal of Nuclear Medicine
Authors: Juhani Knuuti, Małgorzata Kobylecka, Seweryn Krajewski, Lukasz Steczek, Karina Gotowicz, Joanna Towpik, Kari Kalliokoski, Tuula Tolvanen, Magdalena Kostkiewicz, Przemysław Kozanecki, Joanna Włostowska, Mirosław Dziuk, Leszek Królicki, Jacek Bil, Piotr J. Slomka, Timothy M. Bateman, Mouaz H. Al-Mallah, Panithaya Chareonthaitawee, Prem Soman, Cezary Kozanecki
Institutions: University of Turku, Turku University Hospital, Turku PET Centre, Medical University of Warsaw, University of Warsaw, Jagiellonian University, John Paul II Hospital, Affidea, Wojskowy Instytut Medyczny, National Medical Institute of the Ministry of Interior and Administration, Cedars-Sinai Medical Center, Saint Luke's Health System, Saint Luke's Hospital, Houston Methodist, Mayo Clinic, University of Pittsburgh Medical Center
Language: English
Subfield: Radiology, Nuclear Medicine and Imaging
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4408232266