Safety observations in neuroblastoma patients undergoing (18)F- mFBG PET Journal Article
| Authors: | Pandit-Taskar, N.; Basu, E.; Balquin, E.; Mozley, P. D.; Jacobson, A. F.; Modak, S. |
| Article Title: | Safety observations in neuroblastoma patients undergoing (18)F- mFBG PET |
| Abstract: | 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 (NCT 02348749). 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. |
| Keywords: | adolescent; adult; child; clinical article; preschool child; school child; child, preschool; young adult; unclassified drug; clinical trial; drug safety; positron emission tomography; prospective study; phase 2 clinical trial; diagnostic imaging; risk assessment; infant; neuroblastoma; positron-emission tomography; (3 iodobenzyl)guanidine; blood pressure; safety; hot flush; phase 1 clinical trial; fluorine 18; pet; pulse rate; vital sign; adverse events; humans; human; male; female; article; meta-fluorobenzylguanidine; fluorine 3 iodobenzylguanidine f 18 |
| Journal Title: | Nuclear Medicine Communications |
| Volume: | 46 |
| Issue: | 3 |
| ISSN: | 0143-3636 |
| Publisher: | Lippincott Williams & Wilkins |
| Date Published: | 2025-03-01 |
| Start Page: | 245 |
| End Page: | 247 |
| Language: | English |
| DOI: | 10.1097/mnm.0000000000001938 |
| PUBMED: | 39641193 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PDF. Corresponding MSK author is Neeta Pandit-Taskar -- Source: Scopus |
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