Imaging biomarkers in lung cancer

• Research type

  Research Study

• Full title

  MRI measurement of hypoxia in NSCLC: validation and efficacy as response and toxicity biomarkers

• IRAS ID

  167402

• Contact name

  James O'Connor

• Contact email

  james.o'connor@manchester.ac.uk

• Sponsor organisation

  The University of Manchester

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  This is prospective pilot study funded by a grant from Engineering and Physical Sciences Research Council and Cancer Research UK. Patients will be recruited in The Christie NHS Foundation Trust and University Hospital of South Manchester NHS Foundation Trust (Wythenshawe Hospital) and will be asked to give blood samples and undergo oxygen-enhanced magnetic resonance imaging (OE-MRI) and dynamic contrast-enhanced MRI (DCE-MRI). A subset will also have [F-18]fluoroazomycin arabinoside(FAZA)/ [O-15]H2O positron emission tomography (PET) scan. Clinical data will be collected from patient notes. Participation in the study will not influence clinical care.

  Tumours with inadequate tumour oxygen levels are termed ‘hypoxic’ and this feature is associated with poor outcome, particularly due to radiotherapy failure. There is a need to develop non-invasive tests that can measure and spatially map tumour hypoxia, to improve radiotherapy and novel drug treatments for these patients.

  There are 4 components to the study:

  1. OE-MRI Reproducibility: The reproducibility of OE-MRI is unknown, so we will determine this in a cohort of 20 patients with solid tumours.

  2. Biological validation: OE-MRI and DCE-MRI signals will be compared with a) gold standard pathology measurements and b) FAZA and H2O PET measurements in 20 patients with lung cancer

  3. Effect of radiotherapy on tumour and normal lung tissue: OE-MRI and DCE-MRI signals will be measured before standard treatments that include radiotherapy and at 1-4 weeks following treatment. This study will involve up to 30 patients with lung cancer. Patients in this group will have up to two baseline MRI scans.

  4. FAZA-PET reproducibility: The reproducibility of FAZA-PET is unknown, so we will determine this in a cohort of 16 patients with lung cancer.

  Patients will be recruited from The Christie (OE-MRI and FAZA-PET reproducibility and treatment components) and Wythenshawe Hospital (biological validation component). The study recruitment will occur over 3 years.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  15/NW/0264

• Date of REC Opinion

  28 Apr 2015

• REC opinion

  Further Information Favourable Opinion