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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002027-17 | EudraCT Number |
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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| University of Sheffield | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhalation of hyperpolarized xenon | Experimental | One litre of hyperpolarized xenon to be inhaled during MRI scan of the lungs |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized xenon | Drug | Inhalation of up to one litre of polarized xenon gas, up to four inhalations per day are permitted. |
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| Measure | Description | Time Frame |
|---|---|---|
| Imaging parameters from MRI scan after inhalation of hyperpolarized xenon gas | 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 | Up to one year after first scan |
| Measure | Description | Time Frame |
|---|---|---|
| To produce and confirm reliability of maps to show regional blood perfusion in the lung area | Maps of the dissolved fraction of Xe-129 to show hyperpolarized xenon transferred from the lungs to the blood | On entry to the study and one year later |
| Repeatability of the 129-Xe MR scans |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fergus V Gleeson | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford University Hospitals NHS Trust | Oxford | England | OX3 7LE | United Kingdom |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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Compare scans on the same day with the patient prone and supine. Compare scans taken supine one year apart |
| On study entry and one year later |