King’s Research Portal Document Version Publisher's PDF, also known as Version of record Link to publication record in King's Research Portal Citation for published version (APA): Young, J., Jauregui-Osoro, M., Wong, W. L., Cooper, M., Cook, G., Barrington, S., Ma, M., Blower, P., & Aboagye, E. O. (2021). An Overview of Nuclear Medicine Research in the UK and the Landscape for Clinical Adoption. Nuclear Medicine Communications. Citing this paper Please note that where the full-text provided on King's Research Portal is the Author Accepted Manuscript or Post-Print version this may differ from the final Published version. If citing, it is advised that you check and use the publisher's definitive version for pagination, volume/issue, and date of publication details. And where the final published version is provided on the Research Portal, if citing you are again advised to check the publisher's website for any subsequent corrections. 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Younga,b, Maite Jauregui-Osorob,c, Wai-Lup Wongd, Margaret S. Coopera, Gary Cooka,b,e, Sally F. Barringtona,e, Michelle T. Maa,b, Philip J. Blowera,b and Eric O. Aboagyeb,c 07/21/2021 on BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8K2+Ya6H515kE= by http://journals.lww.com/nuclearmedicinecomm from Downloaded Background and objectives Nuclear medicine been a requirement to demonstrate both clinical and cost- Downloaded contributes greatly to the clinical management of patients effectiveness. Whilst radiopharmaceuticals for molecular and experimental medicine. This report aims to (1) outline radiotherapy are well suited to these commissioning from the current landscape of nuclear medicine research in pathways, diagnostic radiotracers have not historically http://journals.lww.com/nuclearmedicinecomm the UK, including current facilities and recent or ongoing been assessed in this manner. clinical studies and (2) provide information about the Conclusions We hope that by collating this information available pathways for clinical adoption and NHS funding we will provide stimulus for future discussion and (commissioning) of radiopharmaceuticals. consensus statements around this topic. Nucl Med Methods Evidence was obtained through database Commun XXX: 000–000 Copyright © 2021 The Author(s). searches for UK-based nuclear medicine clinical studies Published by Wolters Kluwer Health, Inc. by and by conducting a questionnaire-based survey of BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8K2+Ya6H515kE= Nuclear Medicine Communications XXX, XXX:000–000 UK radiopharmaceutical production facilities. A recent history of clinical commissioning, either through Keywords: clinical studies, nuclear medicine commissioning, radiotracer production recommendations from the National Institute for Health a and Care Excellence (NICE) or through NHS specialised Department of Imaging Chemistry and Biology, School of Biomedical Engineering and Imaging Sciences, King’s College London, bNational Cancer services commissioning, was compiled from publicly Imaging Translational Accelerator, Cancer Research UK, cDepartment of Surgery d available documents and policies. & Cancer, Division of Cancer, Imperial College London, London, Department of Nuclear Medicine, Mount Vernon Cancer Centre, Mount Vernon Hospital, Northwood and eKing’s College London and Guy’s and St Thomas’ PET Centre, Results The collected data highlighted the UK’s King’s College London, King’s Health Partners, London, UK active nuclear medicine research community and recent investment in new facilities and upgrades. All Correspondence to Eric O. Aboagye, PhD, FMedSci, Department of Surgery & Cancer, Division of Cancer, Imperial College London, London W12 0NN, UK commissioning routes favour radiopharmaceuticals that Tel: +4420 3313 3759; e-mail: [email protected] have marketing authorisation and since 2017 there has Received 26 May 2021 Accepted 21 June 2021 Introduction Gamma-scintigraphy Nuclear medicine is a specialised area of clinical imag- Gamma-scintigraphy, including SPECT, utilises gam- ing and therapy that uses radioactive pharmaceuticals ma-emitting radionuclides for diagnostic imaging of func- (radiopharmaceuticals) to diagnose, evaluate and treat tional, physiological and metabolic processes. SPECT diseases. It includes two diagnostic imaging modalities scans are often co-registered with anatomical CT scans. – gamma-scintigraphy (including single-photon emission In the UK, the most common gamma-scintigraphy scans on computed tomography (SPECT)) and PET – and a treat- include bone, lung, myocardium and kidney scans [5]. 07/21/2021 ment modality – targeted radionuclide therapy or molec- Over 85% of procedures utilise radiotracers incorporating ular radiotherapy (MRT). Over 650 000 National Health technetium-99m, which emits 140 keV gamma photons Service (NHS) diagnostic imaging procedures utilised a [5]. This has a 6-h half-life, so 99mTc-labelled radiotracers diagnostic radiopharmaceutical (radiotracer) in the year must be produced on the day of administration, typically 2019–2020 [1–3]. MRT is a smaller but rapidly expanding at hospital-based radiopharmacy production units (RPUs), area of nuclear medicine (250% increase since 2007) with from nonradioactive starting materials (radiopharma- over 6000 procedures conducted in the UK in 2017 [4]. ceutical kits) and a source of technetium-99m (molyb- denum-99/technetium-99m generator), using aseptic techniques. Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's website, www.nuclearmedicinecomm.com. PET PET is a diagnostic imaging technique that uses posi- This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduc- tron-emitting radionuclides and locates the radiotracer tion in any medium, provided the original work is properly cited. using the two 511 keV photons emitted in opposite 0143-3636 Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. DOI: 10.1097/MNM.0000000000001461 Copyright © 2021 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 2 Nuclear Medicine Communications XXX, Vol XXX No XXX directions when positrons and electrons mutually anni- and the ISRCTN registry (all free access databases), hilate. PET data are typically co-registered with anatom- for UK nuclear medicine studies starting between 2015 ical imaging on PET-CT, PET-MRI or more recently and 2020 (inclusive), using the search terms in Table 1. total-body PET-CT scanners [6,7]. The most com- Results, sorted as described in Fig. 1, included all studies monly used PET radionuclide, fluorine-18, has a half- in which a radiotracer was used, including studies where life of 109.8 min and is produced in a compact particle the research focus was on the radiopharmaceutical and accelerator – a cyclotron. It can then be combined with studies where the radiopharmaceutical was used only for nonradioactive chemical precursors to yield the desired screening or monitoring. Further data, such as the radi- 18F-labelled radiotracer, which is administered on the day opharmaceutical used (which in some cases was inferred of manufacture. The most common PET radiotracer is from how it was used; e.g. [18F]FDG was the presumed [18F]Fluorodeoxyglucose ([18F]FDG), a radioactive glu- radiotracer when PET-CT was used to stage tumours) cose analogue used for imaging a wide range of cancers, and whether the study was a clinical trial of an investi- myocardial viability, vasculitis, infection and neurological gational medicinal product (CT(IMP)), were extracted disorders [8]. [18F]FDG accounts for over 90% of clinical manually from each study record to ensure equivalent PET-CT scans in England [9]. data were available for each study regardless of the data- base it originated from. Molecular radiotherapy All interventional studies categorised as phase 1 4 trials MRT utilises alpha- or beta-emitting radionuclides, – were inferred to be CT(IMP)s and reviewed against the typically with half-lives in the order of days that have Medicines and Healthcare products Regulatory Agency a therapeutic effect when accumulated at disease sites. 131 (MHRA) algorithm ‘Is it a clinical trial of a medicinal prod- The most common form of MRT in the UK is [ I]NaI uct?’ [12] to classify the radiotracers either as investiga- (sodium iodide), used to