Oxford University Hospitals NHS Trust
Oxford, England, OX3 7LE, United Kingdom
NCT Number: NCT02112929
The investigators aim to use hyperpolarized xenon gas magnetic resonance imaging (MRI) and computed tomography to develop a new technique capable of objectively and quantitatively describing regional and structural lung abnormality. Since this is a relatively novel technique, the investigators first need to acquire imaging and clinical data from a group of participants with normal lungs. The investigators hope to generate an "atlas" of normality, which will form the foundation of future studies to compare with patients suffering from chronic respiratory disease. The investigators also aim to validate the new technique in terms of intra-subject reproducibility.
Looking for future studies?
Notify Me18 year and older
Male
Interventional
Phase 1
Oxford, England, OX3 7LE, United Kingdom
Currently, the gold standard for assessment of lung function in chronic respiratory disease is spirometry. This is combined with anatomical imaging (chest x-ray and computed tomography) for structural assessment. Spirometry only measures global lung function. It provides no information regarding the different regions of the lung or about the supporting "framework" of the lung itself, the parenchyma. In addition, changes in lung function as measured with spirometric indices do not correlate coherently with the symptoms experienced by patients, nor reflect their decline in health. This weak relationship is probably because the lung is a complex regional organ where localized disturbances of a variety of factors including gas flow (ventilation), blood flow (perfusion) and gas transfer all combine to impair respiratory function.
MRI has the advantage of being an imaging technique free from ionizing radiation making it safe and practical for diseases such as asthma and obstructive lung disease where repeated follow-up scans are necessary. Hyperpolarized xenon, in the doses given for imaging has been shown to be safe. Conventional MRI has limited use in respiratory disease, because the lung is largely composed of air spaces that do not generate an MR signal. Hyperpolarized noble gases can resolve this problem.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Inhalation of up to one litre of polarized xenon gas, up to four inhalations per day are permitted.
Time frame: Up to one year after first scan
Maps of Apparent Diffusion Coefficient and objective measures of regional lung Production of Xe-129 ADC maps co-registered to CT and objective measures of regional lung anatomy, ventilation and perfusion in normals with hyperpolarized Xe-129 MR imaging (ADC quantification in cm2s-1). Derivation of reproducibility data
Time frame: On entry to the study and one year later
Maps of the dissolved fraction of Xe-129 to show hyperpolarized xenon transferred from the lungs to the blood
Time frame: On study entry and one year later
Compare scans on the same day with the patient prone and supine. Compare scans taken supine one year apart
Oxford University Hospitals NHS Trust
Other
Regional Lung Imaging and Modelling to Quantify Anatomy, Ventilation and Perfusion Using Hyperpolarized Xenon Gas MR and Thoracic CT Imaging
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02234128
Lung Disease, Lung Diseases
Jacksonville, Florida, United States
View Trial DetailsNCT02723474
Lung Disease, Lung Diseases
London, Ontario, Canada
View Trial DetailsNCT00818025
Lung Disease, Lung Diseases
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT02804854
Lung Disease, Lung Diseases
Edinburgh, Edinburgh City, United Kingdom
View Trial Details