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Lung cancer
Accuracy and cost-effectiveness of dynamic contrast-enhanced CT in the characterisation of solitary pulmonary nodules—the SPUtNIk study
  1. N R Qureshi1,
  2. R C Rintoul2,
  3. K A Miles3,
  4. S George4,
  5. S Harris4,
  6. J Madden5,
  7. K Cozens5,
  8. L A Little5,
  9. K Eichhorst5,
  10. J Jones6,
  11. P Moate5,
  12. C McClement5,
  13. L Pike7,
  14. D Sinclair7,
  15. W L Wong8,
  16. J Shekhdar9,
  17. R Eaton9,
  18. A Shah9,
  19. L Brindle10,
  20. C Peebles11,
  21. A Banerjee11,
  22. S Dizdarevic12,
  23. S Han13,
  24. F W Poon13,
  25. A M Groves3,
  26. L Kurban14,
  27. A J Frew12,
  28. M E Callister15,
  29. P Crosbie16,
  30. F V Gleeson17,
  31. K Karunasaagarar18,
  32. O Kankam19 and
  33. F J Gilbert20
  34. on behalf of the SPUTNIK investigators
    1. 1Department of Radiology, Papworth Hospital, Cambridge, UK
    2. 2Department of Thoracic Oncology, Papworth Hospital, Cambridge, UK
    3. 3Institute of Nuclear Medicine, University College London, London, UK
    4. 4Public Health Sciences and Medical Statistics, University of Southampton, Southampton, UK
    5. 5Southampton Clinical Trials Unit, University of Southampton, Southampton, UK
    6. 6Centre for Innovation and Leadership in Health Sciences, University of Southampton, UK
    7. 7Division of Imaging Sciences and Biomedical Engineering, King's College London, London, UK
    8. 8Department of Medical Physics, Paul Strickland Scanner Centre, Mount Vernon Hospital, East and North Herts NHS Trust, Stevenage, UK
    9. 9Radiation Protection Department, East and North Hertfordshire NHS Trust, Stevenage, UK
    10. 10Faculty of Health Sciences, University of Southampton, Southampton, UK
    11. 11Department of Radiology and Respiratory Medicine, Southampton University Hospitals NHS Foundation Trust, Southampton, UK
    12. 12Departments of Respiratory and Nuclear Medicine, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK
    13. 13West of Scotland PET Centre, Gartnavel Hospital, Glasgow, UK
    14. 14Department of Radiology, Aberdeen Royal Hospitals NHS Trust, Aberdeen, UK
    15. 15Department of Respiratory Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK
    16. 16North West Lung Centre, University Hospital of South Manchester, Manchester, UK
    17. 17Department of Radiology, Churchill Hospital and University of Oxford, Oxford, UK
    18. 18Department of Radiology, Worcestershire Royal Hospital, Worcester, UK
    19. 19Department of Thoracic Medicine, East Sussex Hospitals NHS Trust, Saint Leonards-on-Sea, UK
    20. 20Department of Radiology, University of Cambridge School of Clinical Medicine, Biomedical research centre, University of Cambridge, Cambridge, UK
    1. Correspondence to Professor FJ Gilbert; fjg28{at}medschl.cam.ac.uk

    Abstract

    Introduction Solitary pulmonary nodules (SPNs) are common on CT. The most cost-effective investigation algorithm is still to be determined. Dynamic contrast-enhanced CT (DCE-CT) is an established diagnostic test not widely available in the UK currently.

    Methods and analysis The SPUtNIk study will assess the diagnostic accuracy, clinical utility and cost-effectiveness of DCE-CT, alongside the current CT and 18-flurodeoxyglucose-positron emission tomography) (18FDG-PET)-CT nodule characterisation strategies in the National Health Service (NHS). Image acquisition and data analysis for 18FDG-PET-CT and DCE-CT will follow a standardised protocol with central review of 10% to ensure quality assurance. Decision analytic modelling will assess the likely costs and health outcomes resulting from incorporation of DCE-CT into management strategies for patients with SPNs.

    Ethics and dissemination Approval has been granted by the South West Research Ethics Committee. Ethics reference number 12/SW/0206. The results of the trial will be presented at national and international meetings and published in an Health Technology Assessment (HTA) Monograph and in peer-reviewed journals.

    Trial registration number ISRCTN30784948; Pre-results.

    • Lung Cancer
    • Imaging/CT MRI etc

    This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

    https://doi.org/10.1136/bmjresp-2016-000156

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      Footnotes

      • Correction notice This article has been corrected since it published Online First. The section heading has been changed to ‘Lung cancer’.

      • Collaborators The SPUtNIk Group: KAM, FJG, SG, SH, JJ, Andrew Clegg, NRQ, RCR, Ashley Groves, FVG, FWP, WLW, Richard Riley, LB, PM, CM, CP, AB, Andrea Lodge, John Buscombe, Theresa Green, Amanda Stone, Neal Navani, Robert Shortman, Gabriella Azzopardi, JS, RE, AS, Lucy Pike, DS, SD, AJF, Sarah Doffman, Janice Bush, Jane Lyttle, Kenneth Jacob, SH, Joris van der Horst, Joseph Sarvesvaran, Barbara McLaren, Lesley Gomersall, Lutfi Kurban, Ravi Sharma, Kathleen Collie, KK, Steve O'Hickey, Jayne Tyler, Sue King, John O'Brien, Rajiv Srivastava, Hugh Lloyd-Jones, Sandra Beech, Matthew Callister, Andrew Scarsbrook, Victoria Ashford-Turner, PC, Elaine Smith, Susan Mbale, Nick Adams, Osei Kankam, Gail Pottinger.

      • Contributors KAM, FJG, SG, SH, JJ, Andrew Clegg, AMG, Tony Frew, FVG, FWP, WLW and Richard Riley designed the study and obtained funding. Andrea Lodge, Theresa Green, Amanda Stone, Rob Shortman, Gabriella Azzopardi, Kathleen Collie, Barbara Mclaren, June Innes, Kenneth Jacob, Jane Lyttle, Victoria Ashford-Turner, Susan Mbale, Jayne Tyler, Hugh Lloyd-Jones, Sandra Beech and Gail Pottinger were involved in data acquisition. KAM, FJG, SH, SG, JJ, NRQ, RCR, Andrew Clegg, AMG, FVG, FWP and RR were involved in data analysis and interpretation. RCR, FJG, NRQ, KAM, SG, SH, JJ, JM were involved in manuscript draft and revision for intellectual content. All members of the SPUtNIk Group were involved in approval of the final version. FJG is the guarantor of the study.

      • Funding Health Technology Assessment Programme (09/22/117).

      • Competing interests None declared.

      • Patient consent Obtained.

      • Ethics approval South West-Exeter.

      • Provenance and peer review Not commissioned; internally peer reviewed.

      • Data sharing statement Details of the methods used are freely available to any researcher wishing to use them.