Safety observations in neuroblastoma patients undergoing 18 F- m FBG PET.

Objective: Limited safety data have been published on fluorine-18 ( 18 F) meta-fluorobenzylguanidine ( m FBG), a new PET radiopharmaceutical for imaging neural crest and neuroendocrine tumors. As part of a prospective clinical trial, safety data in patients with neuroblastoma were collected and analyzed.

Methods: Between April 2015 and January 2022, 27 patients with neuroblastoma underwent 18 F- m FBG PET imaging as part of an ongoing single-center phase 1/2 trial (NCT02348749). Pre- and postinjection safety assessments were performed, including vital sign measurement and observation for occurrence of adverse events (AEs).

Results: m FBG administration resulted in no significant changes in measured vital signs. Two subjects had transient, grade 1 facial flushing shortly after the administration, which resolved within a few minutes. Neither subject had a clinically significant change in pulse or blood pressure on postadministration measurements.

Conclusion: In this investigation of the potential clinical utility of m FBG PET imaging, no significant adverse safety signals were noted. Two mild, self-limited AEs were observed, without associated changes in vital signs. No grade 2 or higher AEs were noted. The findings are consistent with a favorable safety profile for m FBG in the target population of patients with neuroblastoma.