Healthy Lung Study- Development of 3 Tesla MRI Hardware and Software for Helium-3 Gas Imaging of the Lung: Healthy Volunteer Development Study
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|ClinicalTrials.gov Identifier: NCT03169673|
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment|
|Healthy Volunteers||Diagnostic Test: Hyperpolarized Helium 3 Magnetic Resonance Imaging|
During a 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 and/or diffusion weighted 3He 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 ATS guidelines. MedGraphics Elite Series, MedGraphics Corporation. St. Paul, MN USA and/or nDD EasyOne Spirometer, nDD Medical Technologies Inc. Andover, MA 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 MR scanner with the 3He chest coil fitted over their torso and chest. Hearing protection will be provided to each subject to muffle the noise produced by the gradient 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 :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Healthy Lung Study- Development of 3 Tesla MRI Hardware and Software for Helium-3 Gas Imaging of the Lung: Healthy Volunteer Development Study|
|Actual Study Start Date :||September 21, 2007|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2020|
- Diagnostic Test: Hyperpolarized Helium 3 Magnetic Resonance Imaging
Hyperpolarized noble gas imaging using Helium-3 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, 3He 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) [ Time Frame: 5 years ]
- Apparent Diffusion Coefficients (ADC) [ 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): NCT03169673
|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||Study Principal Investigator Robarts Research Institute, The University of Western Ontario|