Longitudinal 3He Magnetic Resonance Imaging of Healthy Lung
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|ClinicalTrials.gov Identifier: NCT02483403|
Recruitment Status : Recruiting
First Posted : June 26, 2015
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: Hyperpolarized Helium-3 Device: MRI||Not Applicable|
Briefly, during a single four hour visit, subjects will perform: 1) physical exam, 2) full pulmonary function tests, 3) cycle ergometry, 4) dyspnea and exertions scores using Borg scales, 5) BOLD Questionnaire and 6) 3He MRI before and after bronchodilation by deep inspiration, and potentially 25 minutes after inhalation of 2 puffs (200 µg) of the short-acting bronchodilator salbutamol in subjects who do not respond with 3He MRI ventilation improvements to deep inhalation. Hand-held spirometry will be performed post deep inspiration, and post salbutamol in those who receive salbutamol.
Subjects will first provide written informed consent and then be screened for MRI compatibility and will complete dyspnea and exertion scales, and full pulmonary function tests. A physical exam including vital signs and medical and smoking history will be performed. Subjects will complete the Bold Occupational Questionnaire and rest for approximately 15 minutes before cycle ergometry, including pre-and-post Borg scale evaluations. After completion of cycle ergometry, subjects will rest upright for 15 minutes and prepare for MRI which will be performed on 3 occasions within 1 hour: 1) before deep inspiration, 2) 3 minutes later after deep inspiration and, 3) 25 minutes later after inhalation of 2 puffs of salbutamol in subjects who do not respond to deep inhalation. Images obtained post deep inhalation will be assessed on the spot to determine if administration of salbutamol is required to resolve ventilation defects. Hand-held spirometry will also be performed post deep inspiration and post salbutamol in those who receive salbutamol.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Longitudinal 3He Magnetic Resonance Imaging of Healthy Lung|
|Actual Study Start Date :||September 2010|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2022|
Healthy elderly volunteers will undergo pulmonary function tests, hyperpolarized Helium-3 MRI at each visit.
Other: Hyperpolarized Helium-3
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, Helium-3 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: 3 years ]
- Apparent Diffusion Coefficients (ADC) [ Time Frame: 3 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): NCT02483403
|Contact: Grace E Parraga, PhDemail@example.com|
|Contact: Lyndsey A Reid-Jones, RPN||519-931-5777 ext firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Grace E Parraga, PhD||Robarts Research Institute, The University of Western Ontario|