Trials / Completed
CompletedNCT02483403
Longitudinal 3He Magnetic Resonance Imaging of Healthy Lung
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Western University, Canada · Academic / Other
- Sex
- All
- Age
- 60 Years – 90 Years
- Healthy volunteers
- Accepted
Summary
Healthy elderly subjects male and female aged 65-85 will undergo MRI, lung function and exercise testing for the development of tools to quantify and validate longitudinal in vivo magnetic resonance imaging phenotypes of the aging lung.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DEVICE | MRI |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2025-01-01
- Completion
- 2025-01-01
- First posted
- 2015-06-26
- Last updated
- 2025-08-11
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02483403. Inclusion in this directory is not an endorsement.