129 Xenon MRI in Chronic Lung Disease
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|ClinicalTrials.gov Identifier: NCT02723500|
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Disease||Device: Hyperpolarized Xenon MRI||Not Applicable|
Briefly, during a one to two hour visit, subjects will provide written informed consent and then undergo:
- brief medical history and vital signs,
- full pulmonary function tests,
- proton MRI,
- spin-density and/or diffusion weighted 129Xe MRI.
Full pulmonary function tests including spirometry, plethysmography and diffusing capacity of carbon monoxide (DLCO), Lung Clearance Index (LCI) and Airwave Oscillometry (AO) 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 the 129Xe chest coil 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Study Evaluating Hyperpolarized 129 Xenon Magnetic Resonance Imaging in Subjects With Chronic Lung Disease|
|Actual Study Start Date :||August 2011|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
MRI at baseline and over time
Patients with chronic lung disease will undergo pulmonary function tests, hyperpolarized Xenon MRI at each visit.
Device: Hyperpolarized Xenon MRI
Hyperpolarized 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.
- Ventilation Defect Percent (VDP) of the lung [ Time Frame: 5 years ]
- Apparent Diffusion Coefficients (ADC) of the lung [ Time Frame: 5 years ]
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): NCT02723500
|Contact: Grace E Parraga, PhDfirstname.lastname@example.org|
|Contact: Lyndsey A Reid-Jones, RPN||519-931-5777 ext email@example.com|
|Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre||Recruiting|
|London, Ontario, Canada, N6A 5B7|
|Contact: Grace E Parraga, PhD 519-931-5265 firstname.lastname@example.org|
|Principal Investigator:||Grace E Parraga, PhD||Robarts Research Institute, The University of Western Ontario|