Regional Lung Imaging Using Hyperpolarized Xenon Gas
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|ClinicalTrials.gov Identifier: NCT02112929|
Recruitment Status : Unknown
Verified June 2016 by Fergus Gleeson, Oxford University Hospitals NHS Trust.
Recruitment status was: Recruiting
First Posted : April 14, 2014
Last Update Posted : June 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lung Disease||Drug: Hyperpolarized xenon||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Regional Lung Imaging and Modelling to Quantify Anatomy, Ventilation and Perfusion Using Hyperpolarized Xenon Gas MR and Thoracic CT Imaging|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||March 2017|
Experimental: Inhalation of hyperpolarized xenon
One litre of hyperpolarized xenon to be inhaled during MRI scan of the lungs
Drug: Hyperpolarized xenon
Inhalation of up to one litre of polarized xenon gas, up to four inhalations per day are permitted.
- Imaging parameters from MRI scan after inhalation of hyperpolarized xenon gas [ 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
- To produce and confirm reliability of maps to show regional blood perfusion in the lung area [ 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
- Repeatability of the 129-Xe MR scans [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112929
|Oxford University Hospitals NHS Trust||Recruiting|
|Oxford, England, United Kingdom, OX3 7LE|
|Contact: Jennifer M Lee firstname.lastname@example.org|
|Principal Investigator: Fergus V Gleeson|
|Principal Investigator:||Fergus V Gleeson||Oxford University Hospitals NHS Trust|