VERIFY

  • Research type

    Research Study

  • Full title

    Validation of the analysis methodology behind the use of quantitative 2-deoxy-2-[fluorine-18] fluoro-D-glucose (18F-FDG) Positron Emission Tomography/Computed Tomography (PET/CT) to assess lung inflammation

  • IRAS ID

    220307

  • Contact name

    Joseph Cheriyan

  • Contact email

    jc403@medschl.cam.ac.uk

  • Sponsor organisation

    Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

  • Duration of Study in the UK

    1 years, 5 months, 1 days

  • Research summary

    Inflammation plays an important role in a myriad of human diseases. Interstitial Lung Diseases (ILDs) are characterised by widespread inflammation and represent a major burden to the health sector.

    Imaging offers a method of assessing lung inflammation which is non-invasive and may help facilitate the development of new therapeutic drugs. Positron Emission Tomography (PET) is a sensitive imaging modality that uses radioactive material to highlight areas of disease. 18F-FDG is the most common radioactive tracer; it accumulates in cells with an increased metabolic rate. Previous studies have shown that inflammatory cells have an increased metabolic rate, thus PET imaging could highlight inflammation. 18F-FDG PET has been used in many lung diseases; the concentration of tracer is thought to relate to the severity of inflammation.

    There is currently no standardised method to analyse FDG-PET scans to assess the concentration of tracer in the lung (and therefore inflammation). A major challenge is providing corrections to ensure that the image only represents tracer in the lung tissue. Such corrections are non-trivial and affect how we interpret the images. A robust validation is needed to ensure that the analysis methods used in FDG-PET images truly represent the degree of lung inflammation.

    This study aims to validate and compare the different analysis methods. Pulmonary sarcoidosis patients, a disease characterised by widespread lung inflammation, will provide validation of the technique. Healthy volunteers will be recruited to assess the reliability of the analysis methods.

    Our aims are:

    To compare FDG-PET derived tissue inflammation measures against measures of inflammation from BAL samples.

    To compare different models of 18F-FDG lung analysis in patients with pulmonary sarcoidosis.

    To identify whether FDG PET is sensitive enough to detect a change in inflammation induced in healthy volunteers.

  • REC name

    South Central - Berkshire B Research Ethics Committee

  • REC reference

    17/SC/0482

  • Date of REC Opinion

    9 Oct 2017

  • REC opinion

    Further Information Favourable Opinion