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Xe129 Magnetic Resonance Imaging of the Lung: A New Technology to Assess Treatment for COPD
Sponsor study identifier
interventional
30
1 country
1
Study Start
May 1, 2016
Actual (reported)Primary Completion
June 15, 2018
Actual (reported)Study Completion
June 15, 2018
Actual (reported)First, the investigators will image patients with hyperpolarized xenon (Xe) magnetic resonance imaging (MRI) to develop the technique of hyperpolarized xenon MRI at the University of Virginia (UVA). Magnetic Resonance (MR) sequences will need to be developed and optimized for the equipment at UVA. These sequences will need to be evaluated in healthy adults for comparison with results obtained and in adults with lung diseases to optimize the sequences for the detection and evaluation of lung diseases. The MR pulse sequences need to be optimized for the parameters of a human MR coil and the gas exchange characteristics in healthy and diseased lungs. Second, the investigators propose to exploit the power of Xe129 MRI as a diagnostic tool to monitor therapeutic responses of a combination inhaler, Advair, which contains a long-acting beta-adrenoceptor agonist (LABA) and an inhaled corticosteroid (ICS) - two major classes of the current COPD therapeutics. The investigators will characterize the functional changes of the lungs with COPD at baseline, and investigate the responses of the lungs to the treatment after a three-month trial. Also the investigators will compare corresponding results obtained by Xe129 dissolved phase (DP) MRI to the results obtained by gadolinium-based dynamic contrast-enhanced perfusion MRI (perfusion MRI) and high resolution computed tomography (HRCT) of the lung to indirectly validate the Xe129 DP MRI technique. The investigators anticipate that the results from this project will greatly improve the investigators understanding of the lung functional responses of COPD subjects to current therapeutics. Also, the investigators expect that this project will provide evidence to consider Xe129 MRI as a diagnostic strategy to assess and monitor therapeutic responses of existing and new pharmaceuticals, and thus Xe129 MRI will stimulate development of novel therapies for COPD in the future
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 15, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2016
Actual (reported)May 10, 2016
Actual (reported)July 11, 2016
Actual (reported)June 15, 2018
Actual (reported)June 15, 2018
Actual (reported)Improvement in pulmonary airflow physiology detected by Xenon129 MRI
MRI will determine anticipated improvement in patients' airflow limitation correlation ventilation defect.
From baseline to 3 month post treatment with Advair
Improvement in pulmonary gas exchange physiology detected by Xenon129 MRI
Dissolved phase Xe129 of the MRI will determine anticipated improvement in patients' gas exchange capacity in lung tissues correlating with tissue damage caused by COPD.
From baseline to 3 month post treatment with Advair
Improvement in clinical pulmonary function test
From baseline to 3 month post treatment with Advair
St. George's Respiratory Questionnaire
From baseline to 3 month post treatment with Advair
Baseline Dyspnea Index
From baseline to 3 month post treatment with Advair
Transition Dyspnea Index
From baseline to 3 month post treatment with Advair
Chronic Respiratory Questionnaire
From baseline to 3 month post treatment with Advair
Subjects will undergo hyperpolarized xenon MRI with perfusion imaging, before and after a 90 day course of Adair. All subjects belong to one arm and will receive same treatment. Then they are compared at baseline and 3 month post intervention (described below) for within same-subject changes. Subjects will be administered with 1. Hyperpolarized Xenon129 inhalation during MRI twice (at baseline and post 3 month Advair) 2. Gadolinium intravenous contrast during MRI twice (at baseline and post 3 month Advair) 3. Advair diskus: strength 250mcg/50mcg, one puff twice a day for 3 months.
subjects will receive at baseline and 3 month post Advair intervention (See next intervention)
subjects will receive at baseline and 3 month post Advair intervention (See next intervention)
University of Virginia
Charlottesville, Virginia, 22908, United States
Y Michael Shim, MD
University of Virginia
30 participants (actual enrollment reported by the registry).
First Submitted
May 10, 2016
First Posted
July 11, 2016
Study Start
May 1, 2016
Actual (reported)subjects will receive for 3 month duration between baseline and 3 month post Xenon129 MRI imaging and Gadolinium MRI.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 15, 2018
Actual (reported)Study Completion
June 15, 2018
Actual (reported)Last Updated
November 4, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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