Radiopharmaceutical Validation for Clinical Use
Radiopharmaceuticals are reemerging as attractive anticancer agents, but there are no universally adopted guidelines or standardized procedures for evaluating agent validity before early-phase trial implementation. To validate a radiopharmaceutical, it is desirous for the radiopharmaceutical to be s...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2021-03-01
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| Series: | Frontiers in Oncology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2021.630827/full |
| _version_ | 1818434207469273088 |
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| author | Charles A. Kunos Rodney Howells Aman Chauhan Zin W. Myint Mark E. Bernard Riham El Khouli Jacek Capala |
| author_facet | Charles A. Kunos Rodney Howells Aman Chauhan Zin W. Myint Mark E. Bernard Riham El Khouli Jacek Capala |
| author_sort | Charles A. Kunos |
| collection | DOAJ |
| description | Radiopharmaceuticals are reemerging as attractive anticancer agents, but there are no universally adopted guidelines or standardized procedures for evaluating agent validity before early-phase trial implementation. To validate a radiopharmaceutical, it is desirous for the radiopharmaceutical to be specific, selective, and deliverable against tumors of a given, molecularly defined cancer for which it is intended to treat. In this article, we discuss four levels of evidence—target antigen immunohistochemistry, in vitro and in vivo preclinical experiments, animal biodistribution and dosimetry studies, and first-in-human microdose biodistribution studies—that might be used to justify oncology therapeutic radiopharmaceuticals in a drug-development sequence involving early-phase trials. We discuss common practices for validating radiopharmaceuticals for clinical use, everyday pitfalls, and commonplace operationalizing steps for radiopharmaceutical early-phase trials. We anticipate in the near-term that radiopharmaceutical trials will become a larger proportion of the National Cancer Institute Cancer Therapy Evaluation Program (CTEP) portfolio. |
| first_indexed | 2024-12-14T16:33:19Z |
| format | Article |
| id | doaj.art-0a22045efcf944778aceb5256be6b844 |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-12-14T16:33:19Z |
| publishDate | 2021-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-0a22045efcf944778aceb5256be6b8442022-12-21T22:54:32ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2021-03-011110.3389/fonc.2021.630827630827Radiopharmaceutical Validation for Clinical UseCharles A. Kunos0Rodney Howells1Aman Chauhan2Zin W. Myint3Mark E. Bernard4Riham El Khouli5Jacek Capala6Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, United StatesCancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, United StatesDivision of Medical Oncology, Department of Internal Medicine, University of Kentucky, Lexington, KY, United StatesDivision of Medical Oncology, Department of Internal Medicine, University of Kentucky, Lexington, KY, United StatesDepartment of Radiation Medicine, University of Kentucky, Lexington, KY, United StatesDivision of Nuclear Medicine and Molecular Imaging, Department of Radiology, University of Kentucky, Lexington, KY, United StatesRadiation Research Program, National Cancer Institute, Bethesda, MD, United StatesRadiopharmaceuticals are reemerging as attractive anticancer agents, but there are no universally adopted guidelines or standardized procedures for evaluating agent validity before early-phase trial implementation. To validate a radiopharmaceutical, it is desirous for the radiopharmaceutical to be specific, selective, and deliverable against tumors of a given, molecularly defined cancer for which it is intended to treat. In this article, we discuss four levels of evidence—target antigen immunohistochemistry, in vitro and in vivo preclinical experiments, animal biodistribution and dosimetry studies, and first-in-human microdose biodistribution studies—that might be used to justify oncology therapeutic radiopharmaceuticals in a drug-development sequence involving early-phase trials. We discuss common practices for validating radiopharmaceuticals for clinical use, everyday pitfalls, and commonplace operationalizing steps for radiopharmaceutical early-phase trials. We anticipate in the near-term that radiopharmaceutical trials will become a larger proportion of the National Cancer Institute Cancer Therapy Evaluation Program (CTEP) portfolio.https://www.frontiersin.org/articles/10.3389/fonc.2021.630827/fullradiopharmaceuticalpreclinicalvalidationnuclear medicineradiation oncology |
| spellingShingle | Charles A. Kunos Rodney Howells Aman Chauhan Zin W. Myint Mark E. Bernard Riham El Khouli Jacek Capala Radiopharmaceutical Validation for Clinical Use Frontiers in Oncology radiopharmaceutical preclinical validation nuclear medicine radiation oncology |
| title | Radiopharmaceutical Validation for Clinical Use |
| title_full | Radiopharmaceutical Validation for Clinical Use |
| title_fullStr | Radiopharmaceutical Validation for Clinical Use |
| title_full_unstemmed | Radiopharmaceutical Validation for Clinical Use |
| title_short | Radiopharmaceutical Validation for Clinical Use |
| title_sort | radiopharmaceutical validation for clinical use |
| topic | radiopharmaceutical preclinical validation nuclear medicine radiation oncology |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2021.630827/full |
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