An interventional study of Hyperpolarized 129Xe MRI in Asthma, Chronic Obstructive Pulmonary Disease and Bronchiectasis, sponsored by McMaster University. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by McMaster University · Not applicable, Interventional, and Basic science
This is a single centre exploratory study that aims to apply hyperpolarized xenon-129 (129Xe) magnetic resonance imaging (MRI) methods and measurements in individual patients with and without lung disease to better understand lung structure and function and evaluate response to therapy delivered as a part of clinical care.
The primary objective of this study is to evaluate the ventilation defect percent (VDP), apparent diffusion coefficient (ADC) and/or the signal-to-noise ratio (SNR) obtained by analysis of hyperpolarized 129Xe MRI at one or more time-points (over time in the absence of therapeutic intervention or following clinically indicated therapy) in healthy volunteers and patients with lung disease including but not limited to: asthma, emphysema, COPD, bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, eosinophilic granulomatosis with polyangiitis and bronchopulmonary dysplasia.
This will be a single centre exploratory study in 10 healthy volunteers with normal lung function and no history of lung disease and 50 patients with a clinical diagnosis of lung disease. There is one study visit required for participation. A subset of participants may be asked to return for up to five additional study visits per year for five years. The purpose of additional study visits is to understand how hyperpolarized 129Xe MRI measurements of lung structure and function change over time in the absence of therapeutic intervention or following clinically indicated therapy.
All subjects will visit St Joseph's Healthcare Hamilton and undergo: vital signs, pulmonary function testing, questionnaires, proton (1H) MRI, static ventilation and/or diffusion-weighted 129Xe MRI, and sputum induction. Up to four doses of hyperpolarized 129Xe will be inhaled during a single study visit.
Inclusion Criteria for participants with lung disease:
Inclusion Criteria for healthy volunteers:
Exclusion Criteria:
Exclusion Criteria for healthy volunteers only:
All enrolled patients will undergo pulmonary function testing, questionnaires, 1H MRI, static ventilation and/or diffusion-weighted hyperpolarized 129Xe MRI and sputum induction at one or more timepoints over five years.
Other: Hyperpolarized 129Xe MRI
Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas is a research approach for the non-invasive visualization and measurement of lung structure and function.
Ventilation Defect Percent (VDP)
Whole lung and lobe specific ventilation defect percent (VDP) measured from 129Xe static ventilation magnetic resonance images.
Time frame: 1-5 years
Apparent Diffusion Coefficient (ADC)
Whole lung and lobe specific apparent diffusion coefficient (ADC) measured from 129Xe diffusion-weighted magnetic resonance images.
Time frame: 1-5 years
Signal-to-noise ratio (SNR)
Signal-to-noise ratio (SNR) measured from 129Xe static ventilation and diffusion-weighted magnetic resonance images.
Time frame: 1-5 years
Plan to share: No
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Alpha 1-Antitrypsin Deficiency→
McMaster University