Exploring the Utility of Hyperpolarized 129Xe MRI in Healthy Volunteers and Patients With Lung Disease
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|ClinicalTrials.gov Identifier: NCT03455686|
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Asthma Chronic Obstructive Pulmonary Disease Bronchiectasis Emphysema Pulmonary Fibrosis Bronchopulmonary Dysplasia Alpha 1-Antitrypsin Deficiency Sarcoidosis, Pulmonary||Other: Hyperpolarized 129Xe MRI||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Single-centre Study Exploring the Utility of Hyperpolarized 129Xe Magnetic Resonance Imaging in Healthy Volunteers and Patients With Lung Disease|
|Actual Study Start Date :||April 19, 2018|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2023|
Experimental: Patients with and without lung disease
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) [ Time Frame: 1-5 years ]Whole lung and lobe specific ventilation defect percent (VDP) measured from 129Xe static ventilation magnetic resonance images.
- Apparent Diffusion Coefficient (ADC) [ Time Frame: 1-5 years ]Whole lung and lobe specific apparent diffusion coefficient (ADC) measured from 129Xe diffusion-weighted magnetic resonance images.
- Signal-to-noise ratio (SNR) [ Time Frame: 1-5 years ]Signal-to-noise ratio (SNR) measured from 129Xe static ventilation and diffusion-weighted magnetic resonance images.
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): NCT03455686
|Contact: Sarah Svenningsen, PhD||(905) 522-1155 ext firstname.lastname@example.org|
|Contact: Melanie Kjarsgaard, RRT||(905) 522-1155 ext email@example.com|
|Firestone Institute for Respiratory Health, St. Joseph's Healthcare||Recruiting|
|Hamilton, Ontario, Canada, L8N 4A6|
|Contact: Sarah Svenningsen, PhD 905-522-1155 ext 37313 firstname.lastname@example.org|
|Principal Investigator:||Parameswaran Nair, MD, PhD||McMaster University|