Hyperpolarized Xenon Gas MR Imaging in NSCLC Radiotherapy

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oxford University Hospitals NHS Trust
• Collaborator: National Institute for Health Research, United Kingdom
• Treatments: Xenon

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