ArticleEJNMMI radiopharmacy and chemistry2020
Use of 55 PET radiotracers under approval of a Radioactive Drug Research Committee (RDRC).
Article in EJNMMI radiopharmacy and chemistry, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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Who cites it
20 citing papers in PubMed.
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- A Full-Spectrum Evaluation of Sigma-1 Receptor (S1R) Positron Emission Tomography (PET) Radioligands from Binding Affinity to Clinical Imaging.Molecules (Basel, Switzerland) · 2025Review
- Total-body positron emission tomography imaging to accelerate radiotracer discovery pipelines.Pharmacological reviews · 2025Review
- Fully Automated Radiosynthesis of No-Carrier-Added [Journal of labelled compounds & radiopharmaceuticals · 2025Article
- Quantitative PET imaging and modeling of molecular blood-brain barrier permeability.Nature communications · 2025Article
- A comparison of routine [EJNMMI radiopharmacy and chemistry · 2024Article
- Performance Characteristics of a New Generation 148-cm Axial Field-of-View uMI Panorama GS PET/CT System with Extended NEMA NU 2-2018 and EARL Standards.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2024Article
- One-Step Synthesis of [ACS central science · 2024Article
- Frontiers in Mass Spectrometry-Based Spatial Metabolomics: Current Applications and Challenges in the Context of Biomedical Research.Trends in analytical chemistry : TRAC · 2024Article
- Dosimetry of [EJNMMI radiopharmacy and chemistry · 2023Article
- Regulatory Agencies and PET/CT Imaging in the Clinic.Current cardiology reports · 2022Review
- A Comprehensive Assessment ofJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2022Article
- Synthesis ofNature protocols · 2022Review
- Dual Probes for Positron Emission Tomography (PET) and Fluorescence Imaging (FI) of Cancer.Pharmaceutics · 2022Review
- The Development ofRadiology. Imaging cancer · 2022Review
- A spot test for determination of residual TBA levels inAnalytical methods : advancing methods and applications · 2020Article
- Combining Nuclear Medicine With Other Modalities: Future Prospect for Multimodality Imaging.Molecular imagingArticle
Corrections and comments
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Authors and funding
20 authors.
Funding
Abstract
backgroundIn 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.
resultsThe 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.
conclusionsThe 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.
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