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RecruitingNCT02723500

129 Xenon MRI in Chronic Lung Disease

A Study Evaluating Hyperpolarized 129 Xenon Magnetic Resonance Imaging in Subjects With Chronic Lung Disease

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Western University, Canada · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

Subjects aged 18-85 with lung disease will undergo hyperpolarized Xenon 129 (129-Xe) MRI and Pulmonary Function testing for the development of tools to evaluate the Apparent Diffusion Coefficient (ADC), ventilation defect percent (VDP) and pulmonary gas exchange measurements obtained by analysis of hyperpolarized 129-Xe MRI.

Detailed description

Briefly, during a one to two hour visit, subjects will provide written informed consent and then undergo: 1. brief medical history and vital signs, 2. full pulmonary function tests, 3. proton MRI, 4. spin-density, diffusion weighted, and/or dissolved phase 129-Xe MRI, 5. Low-dose thoracic CT Full pulmonary function tests including spirometry, plethysmography and diffusing capacity of carbon monoxide (DLCO), Multiple Breath Nitrogen Washout (MBNW) to measure Lung Clearance Index (LCI), and Forced Oscillation Technique (FOT) will be performed according to American Thoracic Society (ATS) guidelines. MedGraphics Elite Series, MedGraphics Corporation. St. Paul, Minnesota USA and/or nDD EasyOne Spirometer, nDD Medical Technologies Inc. Andover, Massachusetts USA will be used. All measurements will be performed in the Pulmonary Function Laboratory at Robarts Research Institute. Subjects will be placed in the 3T Magnetic Resonance (MR) scanner with one of three 129-Xe chest coils fitted over their torso and chest. Hearing protection will be provided to each subject to muffle the noise produced by the gradient radiofrequency (RF) coils. A pulse oximeter lead will be attached to all of the subjects to monitor their heart rate and oxygen saturation. MRI will be performed for up to a period of 30 minutes. All subjects will have supplemental oxygen available via nasal cannula at a flow-rate of 2 liters per minute as a precaution in the event of oxygen desaturation. Thoracic low dose CT will be performed with the same inhalation breath-hold volume and maneuver (nitrogen gas only) used for MRI to obtain participant-specific high resolution images of lung anatomy (tissue structure and airway morphology).

Conditions

Interventions

TypeNameDescription
DEVICEHyperpolarized Xenon MRIHyperpolarized noble gas imaging using Xenon-129 has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI imaging, 129Xe gas is used as a contrast agent to directly visualize the airways, and thus ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping.

Timeline

Start date
2011-08-01
Primary completion
2025-12-01
Completion
2025-12-01
First posted
2016-03-30
Last updated
2024-06-13

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02723500. Inclusion in this directory is not an endorsement.