Translation of PET radiotracers for cancer imaging: recommendations from the National Cancer Imaging Translational Accelerator (NCITA) consensus meeting
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 differe...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-01-01
|
| Series: | BMC Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12916-024-03831-z |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832585656200593408 |
|---|---|
| author | Martina A. McAteer Daniel R. McGowan Gary J. R. Cook Hing Y. Leung Tony Ng James P. B. O’Connor Luigi Aloj Anna Barnes Phil J. Blower Kevin M. Brindle John Braun Craig Buckley Daniel Darian Paul Evans Vicky Goh David Grainger Carol Green Matt G. Hall Thomas A. Harding Catherine D. G. Hines Simon J. Hollingsworth Penny L. Hubbard Cristinacce Rowland O. Illing Martin Lee Baptiste Leurent Sue Mallett Radhouene Neji Natalia Norori Nora Pashayan Neel Patel Kieran Prior Thomas Reiner Adam Retter Alasdair Taylor Jasper van der Aart Joseph Woollcott Wai-Lup Wong Jan van der Meulen Shonit Punwani Geoff S. Higgins |
| author_facet | Martina A. McAteer Daniel R. McGowan Gary J. R. Cook Hing Y. Leung Tony Ng James P. B. O’Connor Luigi Aloj Anna Barnes Phil J. Blower Kevin M. Brindle John Braun Craig Buckley Daniel Darian Paul Evans Vicky Goh David Grainger Carol Green Matt G. Hall Thomas A. Harding Catherine D. G. Hines Simon J. Hollingsworth Penny L. Hubbard Cristinacce Rowland O. Illing Martin Lee Baptiste Leurent Sue Mallett Radhouene Neji Natalia Norori Nora Pashayan Neel Patel Kieran Prior Thomas Reiner Adam Retter Alasdair Taylor Jasper van der Aart Joseph Woollcott Wai-Lup Wong Jan van der Meulen Shonit Punwani Geoff S. Higgins |
| author_sort | Martina A. McAteer |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a781bcff4ba54b438ac22c63598aa0c4 |
| institution | Kabale University |
| issn | 1741-7015 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medicine |
| spelling | doaj-art-a781bcff4ba54b438ac22c63598aa0c42025-01-26T12:37:27ZengBMCBMC Medicine1741-70152025-01-0123111410.1186/s12916-024-03831-zTranslation of PET radiotracers for cancer imaging: recommendations from the National Cancer Imaging Translational Accelerator (NCITA) consensus meetingMartina A. McAteer0Daniel R. McGowan1Gary J. R. Cook2Hing Y. Leung3Tony Ng4James P. B. O’Connor5Luigi Aloj6Anna Barnes7Phil J. Blower8Kevin M. Brindle9John Braun10Craig Buckley11Daniel Darian12Paul Evans13Vicky Goh14David Grainger15Carol Green16Matt G. Hall17Thomas A. Harding18Catherine D. G. Hines19Simon J. Hollingsworth20Penny L. Hubbard Cristinacce21Rowland O. Illing22Martin Lee23Baptiste Leurent24Sue Mallett25Radhouene Neji26Natalia Norori27Nora Pashayan28Neel Patel29Kieran Prior30Thomas Reiner31Adam Retter32Alasdair Taylor33Jasper van der Aart34Joseph Woollcott35Wai-Lup Wong36Jan van der Meulen37Shonit Punwani38Geoff S. Higgins39Department of Oncology, University of OxfordDepartment of Oncology, University of OxfordSchool of Biomedical Engineering and Imaging Sciences, King’s College LondonCRUK Scotland InstituteSchool of Cancer & Pharmaceutical Sciences, King’s College LondonDivision of Cancer Sciences, University of ManchesterDepartment of Radiology, University of CambridgeSoutheast Region, Office of the Chief Scientific Officer, NHS-EnglandSchool of Biomedical Engineering and Imaging Sciences, King’s College LondonCancer Research UK Cambridge Institute, University of CambridgeRMH Radiotherapy Focus Group & RMH Biomedical Research Centre Consumer GroupSiemens Healthcare LimitedSiemens Healthcare LimitedGE HealthCare, Pharmaceutical DiagnosticsSchool of Biomedical Engineering and Imaging Sciences, King’s College LondonMedicines and Healthcare Products Regulatory AgencyPatient and Public RepresentativeNational Physical LaboratoryProstate Cancer UKGSKLate Development Oncology, AstraZenecaDivision of Cancer Sciences, University of ManchesterDepartment of Surgery & Interventional Science, University College LondonClinical Trial and Statistics Unit, Institute of Cancer ResearchDepartment of Statistical Science, University College LondonCentre for Medical Imaging, University College LondonSchool of Biomedical Engineering and Imaging Sciences, King’s College LondonProstate Cancer UKDepartment of Applied Health Research, University College LondonDepartment of Radiology, Churchill Hospital, Oxford University NHS Foundation TrustCancer Research UKEvergreen TheragnosticsCentre for Medical Imaging, University College LondonUniversity Hospitals of Morecambe Bay NHS Foundation Trust, Royal Lancaster InfirmaryGSK Research and DevelopmentProstate Cancer UKPET CT Department, Strickland Scanner Centre Mount Vernon HospitalDepartment of Health Services Research & Policy, London School of Hygiene & Tropical MedicineCentre for Medical Imaging, University College LondonDepartment of Oncology, University of OxfordAbstract 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.https://doi.org/10.1186/s12916-024-03831-zConsensus guidelinesPositron emission tomographyCancer imagingPreclinical evaluationClinical validationTranslational methods |
| spellingShingle | Martina A. McAteer Daniel R. McGowan Gary J. R. Cook Hing Y. Leung Tony Ng James P. B. O’Connor Luigi Aloj Anna Barnes Phil J. Blower Kevin M. Brindle John Braun Craig Buckley Daniel Darian Paul Evans Vicky Goh David Grainger Carol Green Matt G. Hall Thomas A. Harding Catherine D. G. Hines Simon J. Hollingsworth Penny L. Hubbard Cristinacce Rowland O. Illing Martin Lee Baptiste Leurent Sue Mallett Radhouene Neji Natalia Norori Nora Pashayan Neel Patel Kieran Prior Thomas Reiner Adam Retter Alasdair Taylor Jasper van der Aart Joseph Woollcott Wai-Lup Wong Jan van der Meulen Shonit Punwani Geoff S. Higgins Translation of PET radiotracers for cancer imaging: recommendations from the National Cancer Imaging Translational Accelerator (NCITA) consensus meeting BMC Medicine Consensus guidelines Positron emission tomography Cancer imaging Preclinical evaluation Clinical validation Translational methods |
| title | Translation of PET radiotracers for cancer imaging: recommendations from the National Cancer Imaging Translational Accelerator (NCITA) consensus meeting |
| title_full | Translation of PET radiotracers for cancer imaging: recommendations from the National Cancer Imaging Translational Accelerator (NCITA) consensus meeting |
| title_fullStr | Translation of PET radiotracers for cancer imaging: recommendations from the National Cancer Imaging Translational Accelerator (NCITA) consensus meeting |
| title_full_unstemmed | Translation of PET radiotracers for cancer imaging: recommendations from the National Cancer Imaging Translational Accelerator (NCITA) consensus meeting |
| title_short | Translation of PET radiotracers for cancer imaging: recommendations from the National Cancer Imaging Translational Accelerator (NCITA) consensus meeting |
| title_sort | translation of pet radiotracers for cancer imaging recommendations from the national cancer imaging translational accelerator ncita consensus meeting |
| topic | Consensus guidelines Positron emission tomography Cancer imaging Preclinical evaluation Clinical validation Translational methods |
| url | https://doi.org/10.1186/s12916-024-03831-z |
| work_keys_str_mv | AT martinaamcateer translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT danielrmcgowan translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT garyjrcook translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT hingyleung translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT tonyng translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT jamespboconnor translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT luigialoj translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT annabarnes translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT philjblower translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT kevinmbrindle translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT johnbraun translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT craigbuckley translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT danieldarian translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT paulevans translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT vickygoh translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT davidgrainger translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT carolgreen translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT mattghall translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT thomasaharding translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT catherinedghines translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT simonjhollingsworth translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT pennylhubbardcristinacce translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT rowlandoilling translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT martinlee translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT baptisteleurent translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT suemallett translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT radhoueneneji translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT natalianorori translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT norapashayan translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT neelpatel translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT kieranprior translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT thomasreiner translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT adamretter translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT alasdairtaylor translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT jaspervanderaart translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT josephwoollcott translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT wailupwong translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT janvandermeulen translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT shonitpunwani translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting AT geoffshiggins translationofpetradiotracersforcancerimagingrecommendationsfromthenationalcancerimagingtranslationalacceleratorncitaconsensusmeeting |