NCT02826343

New Technology to Assess Treatment for Chronic Obstructive Pulmonary Disease (COPD)

Xe129 Magnetic Resonance Imaging of the Lung: A New Technology to Assess Treatment for COPD

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	Xenon129 MRI imaging	subjects will receive at baseline and 3 month post Advair intervention (See next intervention)
DRUG	Gadolinium MRI	subjects will receive at baseline and 3 month post Advair intervention (See next intervention)
DRUG	Advair (250mcg/50mcg) one puff twice a day	subjects will receive for 3 month duration between baseline and 3 month post Xenon129 MRI imaging and Gadolinium MRI.

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-06-15
• Completion: 2018-06-15
• First posted: 2016-07-11
• Last updated: 2020-11-04

Locations

1 site across 1 country: United States