The final, formatted version of the article will be published soon.
ORIGINAL RESEARCH article
Front. Oncol.
Sec. Cancer Imaging and Image-directed Interventions
Volume 14 - 2024 |
doi: 10.3389/fonc.2024.1445415
Fully-automated production of [ 68 Ga]Ga-Trivehexin for clinical application and its biodistribution in healthy volunteers
Provisionally accepted- 1 Department of Nuclear Medicine, Zhongnan Hospital, Wuhan University, Wuhan, Hubei Province, China
- 2 Clinical Trial Center, Zhongnan Hospital, Wuhan University, Wuhan, Hebei Province, China
Background: The αvβ6-integrin targeting trimeric ligand [ 68 Ga]Ga-Trivehexin has emerged as a promising candidate for clinical application due to its clinical imaging potentials in various malignant cancers. Our objective was to develop a simplified and reproducible module-based automated synthesis protocol to expand its availability in clinical application.The pH value and the precursor load of radiolabeling were explored using an iQS-TS fullyautomated module. Radiochemical purity was evaluated by radio-HPLC and radio-TLC. The ethanol content, radionuclide purity and identity, bacterial endotoxins, sterility, and stability of the final product [ 68 Ga]Ga-Trivehexin were all tested. Biodistribution of [ 68 Ga]Ga-Trivehexin in healthy volunteers was also conducted.The synthesis was explored and established using fully-automated module with outstanding radiochemical purity (>99%). Considering molar activity and economic costs, a pH of 3.6 and precursor dose of 30 μg were determined to be optimal. All relevant quality control parameters were 2 tested and met the requirement of European Pharmacopoeia. In vitro stability test and imaging in healthy volunteer indicated the practical significance in clinical routines.A fully-automated synthesis protocol for [ 68 Ga]Ga-Trivehexin using the iQS-TS synthesis module was achieved and conformed to the clinical quality standards.Trial registration: ClinicalTrials.gov, NCT05835570. Registered 28 April 2023, https://www.clinicaltrials.gov/study/NCT05835570.
Keywords: Fully-automated, Trivehexin, αvβ6-integrin, PET, biodistribution
Received: 07 Jun 2024; Accepted: 16 Jul 2024.
Copyright: © 2024 Wang, Jiang, Zhu, Wu, Wu, Li, Huang, Xiao and He. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Binchen Wang, Department of Nuclear Medicine, Zhongnan Hospital, Wuhan University, Wuhan, 430071, Hubei Province, China
Yaqun Jiang, Department of Nuclear Medicine, Zhongnan Hospital, Wuhan University, Wuhan, 430071, Hubei Province, China
Jiaxu Zhu, Department of Nuclear Medicine, Zhongnan Hospital, Wuhan University, Wuhan, 430071, Hubei Province, China
Huiqin Wu, Department of Nuclear Medicine, Zhongnan Hospital, Wuhan University, Wuhan, 430071, Hubei Province, China
Jianyuan Wu, Clinical Trial Center, Zhongnan Hospital, Wuhan University, Wuhan, 430071, Hebei Province, China
Ling Li, Department of Nuclear Medicine, Zhongnan Hospital, Wuhan University, Wuhan, 430071, Hubei Province, China
Jianying Huang, Clinical Trial Center, Zhongnan Hospital, Wuhan University, Wuhan, 430071, Hebei Province, China
Zhiwei Xiao, Department of Nuclear Medicine, Zhongnan Hospital, Wuhan University, Wuhan, 430071, Hubei Province, China
Yong He, Department of Nuclear Medicine, Zhongnan Hospital, Wuhan University, Wuhan, 430071, Hubei Province, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.