CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Inhalation of hyperpolarized xenon gasdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02151604
NCT02151604Phase 2Completed

A Study to Determine Regional Lung Function in Patients With Non-small Cell Lung Cancer (NSCLC) Undergoing Radiotherapy Using Hyperpolarized Xenon Gas MR Imaging

Oxford University Hospitals NHS Trust·interventional·Posted May 30, 2014·Updated Feb 23, 2023

In Brief

A Phase 2 clinical trial evaluating Inhalation of hyperpolarized xenon gas for Non-small Cell Lung Cancer. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 30, 2014
Enrollment StartApr 23, 2014
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 12.1 years ago

Interventions

Inhalation of hyperpolarized xenon gasdrug

The xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.