Abstract

Background

In the US, EU and elsewhere, basic clinical research studies with positron emission tomography (PET) radiotracers that are generally recognized as safe and effective (GRASE) can often be conducted under institutional approval. For example, in the United States, such research is conducted under the oversight of a Radioactive Drug Research Committee (RDRC) as long as certain requirements are met. Firstly, the research must be for basic science and cannot be intended for immediate therapeutic or diagnostic purposes, or to determine the safety and effectiveness of the PET radiotracer. Secondly, the PET radiotracer must be generally recognized as safe and effective. Specifically, the mass dose to be administered must not cause any clinically detectable pharmacological effect in humans, and the radiation dose to be administered must be the smallest dose practical to perform the study and not exceed regulatory dose limits within a 1-year period. In our experience, the main barrier to using a PET radiotracer under RDRC approval is accessing the required information about mass and radioactive dosing.

Results

The University of Michigan (UM) has a long history of using PET radiotracers in clinical research studies. Herein we provide dosing information for 55 radiotracers that will enable other PET Centers to use them under the approval of their own RDRC committees.

Conclusions

The data provided herein will streamline future RDRC approval, and facilitate further basic science investigation of 55 PET radiotracers that target functionally relevant biomarkers in high impact disease states.

Details

Title
Use of 55 PET radiotracers under approval of a Radioactive Drug Research Committee (RDRC)
Author
Jackson, Isaac M 1 ; Lee So Jeong 2 ; Sowa, Alexandra R 3 ; Rodnick, Melissa E 3 ; Bruton, Laura 3 ; Clark, Mara 3 ; Preshlock Sean 3 ; Rothley Jill 3 ; Rogers, Virginia E 3 ; Botti, Leslie E 3 ; Henderson, Bradford D 3 ; Hockley, Brian G 3 ; Torres Jovany 3 ; Raffel, David M 3 ; Brooks, Allen F 3 ; Frey, Kirk A 3 ; Kilbourn, Michael R 3 ; Koeppe, Robert A 3 ; Shao Xia 3 ; Scott Peter J H 3   VIAFID ORCID Logo 

1  University of Michigan, Department of Radiology, Ann Arbor, USA (GRID:grid.214458.e) (ISNI:0000000086837370); Present Address: Stanford University, Stanford, USA (GRID:grid.168010.e) (ISNI:0000000419368956) 
2  University of Michigan, Department of Radiology, Ann Arbor, USA (GRID:grid.214458.e) (ISNI:0000000086837370); Present Address: Gordon Center for Medical Imaging, Massachusetts General Hospital, Harvard Medical School, Boston, USA (GRID:grid.214458.e) 
3  University of Michigan, Department of Radiology, Ann Arbor, USA (GRID:grid.214458.e) (ISNI:0000000086837370) 
Publication year
2020
Publication date
Dec 2020
Publisher
Springer Nature B.V.
e-ISSN
2365-421X
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s41181-020-00110-z
ProQuest document ID
2471752499
Copyright
© The Author(s) 2020. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.