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Translation of PET radiotracers for cancer imaging: recommendations from the national cancer imaging translational accelerator (NCITA) consensus meeting

McAteer, M. A.
; 
McGowan, D. R.
; 
Cook, G. J. R.
; 
Leung, H. Y.
; 
Ng, T.
; 
O'Connor, J. P. B.
; 
Aloj, L.
; 
Barnes, A.
; 
Blower, P. J.
; 
Brindle, K. M.
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Abstract
BACKGROUND: The clinical translation of positron emission tomography (PET) radiotracers for cancer management presents complex challenges. We have developed consensus-based recommendations for preclinical and clinical assessment of novel and established radiotracers, applied to image different cancer types, to improve the standardisation of translational methodologies and accelerate clinical implementation. METHODS: A consensus process was developed using the RAND/UCLA Appropriateness Method (RAM) to gather insights from a multidisciplinary panel of 38 key stakeholders on the appropriateness of preclinical and clinical methodologies and stakeholder engagement for PET radiotracer translation. Panellists independently completed a consensus survey of 57 questions, rating each on a 9-point Likert scale. Subsequently, panellists attended a consensus meeting to discuss survey outcomes and readjust scores independently if desired. Survey items with median scores ≥ 7 were considered 'required/appropriate', ≤ 3 'not required/inappropriate', and 4-6 indicated 'uncertainty remained'. Consensus was determined as ~ 70% participant agreement on whether the item was 'required/appropriate' or 'not required/not appropriate'. RESULTS: Consensus was achieved for 38 of 57 (67%) survey questions related to preclinical and clinical methodologies, and stakeholder engagement. For evaluating established radiotracers in new cancer types, in vitro and preclinical studies were considered unnecessary, clinical pharmacokinetic studies were considered appropriate, and clinical dosimetry and biodistribution studies were considered unnecessary, if sufficient previous data existed. There was 'agreement without consensus' that clinical repeatability and reproducibility studies are required while 'uncertainty remained' regarding the need for comparison studies. For novel radiotracers, in vitro and preclinical studies, such as dosimetry and/or biodistribution studies and tumour histological assessment were considered appropriate, as well as comprehensive clinical validation. Conversely, preclinical reproducibility studies were considered unnecessary and 'uncertainties remained' regarding preclinical pharmacokinetic and repeatability evaluation. Other consensus areas included standardisation of clinical study protocols, streamlined regulatory frameworks and patient and public involvement. While a centralised UK clinical imaging research infrastructure and open access federated data repository were considered necessary, there was 'agreement without consensus' regarding the requirement for a centralised UK preclinical imaging infrastructure. CONCLUSIONS: We provide consensus-based recommendations, emphasising streamlined methodologies and regulatory frameworks, together with active stakeholder engagement, for improving PET radiotracer standardisation, reproducibility and clinical implementation in oncology.
Authors
McAteer, M. A.
McGowan, D. R.
Cook, G. J. R.
Leung, H. Y.
Ng, T.
O'Connor, J. P. B.
Aloj, L.
Barnes, A.
Blower, P. J.
Brindle, K. M.
Braun, J.
Buckley, C.
Darian, D.
Evans, P.
Goh, V.
Grainger, D.
Green, C.
Hall, M. G.
Harding, T. A.
Hines, C. D. G.
Hollingsworth, S. J.
Cristinacce, P. L. H.
Illing, R. O.
Lee, M.
Leurent, B.
Mallett, S.
Neji, R.
Norori, N.
Pashayan, N.
Patel, N.
Prior, K.
Reiner, T.
Retter, A.
Taylor, A.
van der Aart, J.
Woollcott, J.
Wong, W. L.
van der Meulen, J.
Punwani, S.
Higgins, G. S.
Affiliation
Department of Oncology, University of Oxford, Oxford, UK. martina.mcateer@oncology.ox.ac.uk. Department of Oncology, University of Oxford, Oxford, UK. Department of Medical Physics and Clinical Engineering, Oxford University Hospitals NHS Foundation Trust, Oxford, UK. School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK. King's College London and Guy's and St Thomas' PET Centre, St Thomas' Hospital, London, UK. CRUK Scotland Institute, Glasgow, UK. School of Cancer Sciences, University of Glasgow, Glasgow, UK. School of Cancer & Pharmaceutical Sciences, King's College London, London, UK. Oncology Translational Research, GSK, Stevenage, UK. Division of Cancer Sciences, University of Manchester, Manchester, UK. Division of Radiotherapy and Imaging, Institute of Cancer Research, London, UK. Department of Radiology, University of Cambridge, Cambridge, UK. Southeast Region, Office of the Chief Scientific Officer, NHS-England, England, UK. King's Technology Evaluation Centre (KiTEC), School of Biomedical Engineering & Imaging Science, King's College London, London, UK. Cancer Research UK Cambridge Institute, University of Cambridge, Cambridge, UK. RMH Radiotherapy Focus Group & RMH Biomedical Research Centre Consumer Group, Sutton, UK. Siemens Healthcare Limited, Camberley, UK. GE HealthCare, Pharmaceutical Diagnostics, Chalfont St. Giles, UK. Department of Radiology, NHS Foundation Trust, Guy's and St Thomas, London, UK. Medicines and Healthcare Products Regulatory Agency, London, UK. Patient and Public Representative, Oxford, UK. National Physical Laboratory, Teddington, UK. Prostate Cancer UK, London, UK. Population Health Sciences, University of Bristol, Bristol, UK. GSK, Collegeville, PA, USA. Late Development Oncology, AstraZeneca, Cambridge, UK. Department of Surgery & Interventional Science, University College London, London, UK. Clinical Trial and Statistics Unit, Institute of Cancer Research, Sutton, UK. The Royal Marsden Clinical Research Facility, London, UK. Department of Statistical Science, University College London, London, UK. Centre for Medical Imaging, University College London, London, UK. Department of Applied Health Research, University College London, London, UK. Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK. Department of Radiology, Churchill Hospital, Oxford University NHS Foundation Trust, Oxford, UK. Telix Pharmaceuticals Limited, North Melbourne, Australia. Cancer Research UK, London, UK. Evergreen Theragnostics, Springfield, NJ, 07081, USA. University Hospitals of Morecambe Bay NHS Foundation Trust, Royal Lancaster Infirmary, Lancaster, UK. GSK Research and Development, Hertfordshire, UK. PET CT Department, Strickland Scanner Centre Mount Vernon Hospital, Northwood, UK. Department of Health Services Research & Policy, London School of Hygiene & Tropical Medicine, London, UK. Department of Oncology, University of Oxford, Oxford, UK. geoffrey.higgins@oncology.ox.ac.uk.
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2025
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All Paterson Institute for Cancer Research
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McAteer MA, McGowan DR, Cook GJR, Leung HY, Ng T, O'Connor JPB, et al. Translation of PET radiotracers for cancer imaging: recommendations from the National Cancer Imaging Translational Accelerator (NCITA) consensus meeting. BMC medicine. 2025 Jan 23;23(1):37. PubMed PMID: 39849494. Pubmed Central PMCID: PMC11756105. Epub 2025/01/24. eng.
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https://christie.openrepository.com/handle/10541/628210
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