Safety observations in neuroblastoma patients undergoing 18F-mFBG PET.
| Autor: | Pandit-Taskar N; Departments of Radiology., Basu E; Pediatrics, Memorial Sloan Kettering Cancer Center, New York City, New York., Balquin E; Departments of Radiology., Mozley PD; Innervate Radiopharmaceuticals LLC, Englewood, New Jersey, USA., Jacobson AF; Innervate Radiopharmaceuticals LLC, Englewood, New Jersey, USA., Modak S; Pediatrics, Memorial Sloan Kettering Cancer Center, New York City, New York. |
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| Jazyk: | angličtina |
| Zdroj: | Nuclear medicine communications [Nucl Med Commun] 2024 Dec 06. Date of Electronic Publication: 2024 Dec 06. |
| DOI: | 10.1097/MNM.0000000000001938 |
| Abstrakt: | Objective: Limited safety data have been published on fluorine-18 (18F) meta-fluorobenzylguanidine (mFBG), 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 18F-mFBG 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: mFBG 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 mFBG 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 mFBG in the target population of patients with neuroblastoma. (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.) |
| Databáze: | MEDLINE |
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