Hyperpolarized Xenon Gas MR Imaging in NSCLC Radiotherapy
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Inhalation of hyperpolarized xenon gas
Intervention description: The xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Intervention MeSH terms: Xenon
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Lung cancer is the second most commonly diagnosed cancer in the United Kingdom, accounting
      for 22% of cancer deaths. The main treatments for lung cancer are surgery, radiotherapy or
      chemoradiotherapy. Current methods, for assessing lung function in lung cancer patients i.e.
      spirometry and gas transfer are inadequate. We aim to develop a new technique capable of
      describing regional lung abnormality using hyperpolarized xenon gas MRI.

      The study will involve 50 patients diagnosed with lung cancer considered suitable for radical
      radiotherapy or chemoradiotherapy. Participants will be offered hyperpolarized Xe129 MR at
      baseline, two weeks after commencement of radiotherapy schedules and four followup visits
      over one year posttreatment.

      Patients will undertake extensive study measures at baseline and followup visits, including
      chest CT scans, ventilation/perfusion nuclear medicine scans, gadolinium enhanced MRI scans,
      pulmonary function tests, breathlessness scores, radiotherapy induced lung toxicity
      assessments and exercise testing. Participation in these full tests takes a day, allowing
      patients time to rest between tests and allowing for a period of observation following the
      final hyperpolarized xenon scan.

      The investigators will correlate baseline hyperpolarized Xe129 MR imaging with spirometry and
      breathlessness scores to determine if tolerance for radiotherapy is better predicted by
      hyperpolarized Xe129 MR imaging. The investigators will evaluate changes in hyperpolarized
      Xe129 MR imaging before and after radiotherapy (RT) to determine if it provides better
      monitoring of response compared with spirometry.

      The study will take place at the Churchill Hospital, Oxford University Hospitals National
      Health Service Trust and will be funded by the National Institute for Health Research Oxford
      Biomedical Research Centre. Hyperpolarized Xe129 MR imaging has the potential to inform
      individual suitability for radiotherapy schedules better than the investigations used
      currently. In addition, hyperpolarized Xe129 MR imaging has the potential for better
      monitoring of treatment response and improved detection of radiation induced lung injury,
      invaluable to treating patients with radiation induced injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is willing and able to give informed consent for participation in the
             trial

          -  Male or Female, aged 18 years or above

          -  Histologically verified NSCLC

          -  Patients with any stage NSCLC where radical radiotherapy (with either conventionally
             fractionated treatment or with stereotactic body radiotherapy (SABR)) or
             chemoradiotherapy (concurrent or sequential schedule) is considered appropriate

          -  WHO performance status 0-2

          -  Able (in the Investigators opinion) and willing to comply with all study requirements

        Exclusion Criteria:

          -  Inability to give written informed consent

          -  Female participant who is pregnant, lactating or planning pregnancy during the course
             of the trial

          -  Previous radiotherapy to the chest

          -  The presence of another condition where the disease itself or treatment may interfere
             with the study endpoints

          -  Any psychological, familial, sociological or geographical condition potentially
             hampering compliance with the study protocol and follow-up schedule

          -  Inability to lie flat for imaging

          -  Contraindications to MRI examination including indwelling pacemaker, non-MRI
             compatible metallic implant, severe claustrophobia, intra-ocular foreign body

          -  Contraindications for gadolinium enhanced lung MRI scan - known
             hypersensitivity/allergy to the injection of MultiHance (contains gadobenate
             dimeglumine and small quantities of benzyl alcohol) that is given as part of this
             scanning or an adverse reaction to an injection given during previous MRI scanning,
             severe renal impairment

          -  Contraindications for ventilation/perfusion nuclear medicine scanning - known
             hypersensitivity to albumin or preference to avoid blood donation product

          -  Epilepsy requiring on-going medical treatment, or a seizure within the past year