Ignite Creation Date:
2024-05-06 @ 8:49 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02826343
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2016-05-10
Brief Title:
New Technology to Assess Treatment for Chronic Obstructive Pulmonary Disease COPD
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Xe129 Magnetic Resonance Imaging of the Lung A New Technology to Assess Treatment for COPD
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None