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| Name | Class |
|---|---|
| St. Joseph's Healthcare Hamilton | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with and without lung disease | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized 129Xe MRI | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilation Defect Percent (VDP) | Whole lung and lobe specific ventilation defect percent (VDP) measured from 129Xe static ventilation magnetic resonance images. | 1-5 years |
| Apparent Diffusion Coefficient (ADC) | Whole lung and lobe specific apparent diffusion coefficient (ADC) measured from 129Xe diffusion-weighted magnetic resonance images. | 1-5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Signal-to-noise ratio (SNR) | Signal-to-noise ratio (SNR) measured from 129Xe static ventilation and diffusion-weighted magnetic resonance images. | 1-5 years |
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Inclusion Criteria for participants with lung disease:
Inclusion Criteria for healthy volunteers:
Exclusion Criteria:
Exclusion Criteria for healthy volunteers only:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Svenningsen, PhD | Contact | (905) 522-1155 | 37313 | svennins@mcmaster.ca |
| Melanie Kjarsgaard, RRT | Contact | (905) 522-1155 | 33024 | mkjarsga@stjosham.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Parameswaran Nair, MD, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Firestone Institute for Respiratory Health, St. Joseph's Healthcare | Recruiting | Hamilton | Ontario | L8N 4A6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22104288 | Background | Kirby M, Heydarian M, Svenningsen S, Wheatley A, McCormack DG, Etemad-Rezai R, Parraga G. Hyperpolarized 3He magnetic resonance functional imaging semiautomated segmentation. Acad Radiol. 2012 Feb;19(2):141-52. doi: 10.1016/j.acra.2011.10.007. Epub 2011 Nov 21. | |
| 23239874 | Background | Kirby M, Svenningsen S, Kanhere N, Owrangi A, Wheatley A, Coxson HO, Santyr GE, Paterson NA, McCormack DG, Parraga G. Pulmonary ventilation visualized using hyperpolarized helium-3 and xenon-129 magnetic resonance imaging: differences in COPD and relationship to emphysema. J Appl Physiol (1985). 2013 Mar 15;114(6):707-15. doi: 10.1152/japplphysiol.01206.2012. Epub 2012 Dec 13. |
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| 21105144 | Background | Fain S, Schiebler ML, McCormack DG, Parraga G. Imaging of lung function using hyperpolarized helium-3 magnetic resonance imaging: Review of current and emerging translational methods and applications. J Magn Reson Imaging. 2010 Dec;32(6):1398-408. doi: 10.1002/jmri.22375. |
| 26218920 | Background | Kruger SJ, Nagle SK, Couch MJ, Ohno Y, Albert M, Fain SB. Functional imaging of the lungs with gas agents. J Magn Reson Imaging. 2016 Feb;43(2):295-315. doi: 10.1002/jmri.25002. Epub 2015 Jul 27. |
| 22591724 | Background | Shukla Y, Wheatley A, Kirby M, Svenningsen S, Farag A, Santyr GE, Paterson NA, McCormack DG, Parraga G. Hyperpolarized 129Xe magnetic resonance imaging: tolerability in healthy volunteers and subjects with pulmonary disease. Acad Radiol. 2012 Aug;19(8):941-51. doi: 10.1016/j.acra.2012.03.018. Epub 2012 May 15. |
| 22056683 | Background | Driehuys B, Martinez-Jimenez S, Cleveland ZI, Metz GM, Beaver DM, Nouls JC, Kaushik SS, Firszt R, Willis C, Kelly KT, Wolber J, Kraft M, McAdams HP. Chronic obstructive pulmonary disease: safety and tolerability of hyperpolarized 129Xe MR imaging in healthy volunteers and patients. Radiology. 2012 Jan;262(1):279-89. doi: 10.1148/radiol.11102172. Epub 2011 Nov 4. |
| 23589465 | Background | Svenningsen S, Kirby M, Starr D, Leary D, Wheatley A, Maksym GN, McCormack DG, Parraga G. Hyperpolarized (3) He and (129) Xe MRI: differences in asthma before bronchodilation. J Magn Reson Imaging. 2013 Dec;38(6):1521-30. doi: 10.1002/jmri.24111. Epub 2013 Apr 15. |
| 29313707 | Background | Svenningsen S, Eddy RL, Lim HF, Cox PG, Nair P, Parraga G. Sputum Eosinophilia and Magnetic Resonance Imaging Ventilation Heterogeneity in Severe Asthma. Am J Respir Crit Care Med. 2018 Apr 1;197(7):876-884. doi: 10.1164/rccm.201709-1948OC. |
| 27174885 | Background | Svenningsen S, Nair P, Guo F, McCormack DG, Parraga G. Is ventilation heterogeneity related to asthma control? Eur Respir J. 2016 Aug;48(2):370-9. doi: 10.1183/13993003.00393-2016. Epub 2016 May 12. |
| 22952383 | Background | Kirby M, Svenningsen S, Owrangi A, Wheatley A, Farag A, Ouriadov A, Santyr GE, Etemad-Rezai R, Coxson HO, McCormack DG, Parraga G. Hyperpolarized 3He and 129Xe MR imaging in healthy volunteers and patients with chronic obstructive pulmonary disease. Radiology. 2012 Nov;265(2):600-10. doi: 10.1148/radiol.12120485. Epub 2012 Sep 5. |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001987 | Bronchiectasis |
| D004646 | Emphysema |
| D011658 | Pulmonary Fibrosis |
| D001997 | Bronchopulmonary Dysplasia |
| D019896 | alpha 1-Antitrypsin Deficiency |
| D017565 | Sarcoidosis, Pulmonary |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017563 | Lung Diseases, Interstitial |
| D005355 | Fibrosis |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D013352 | Subcutaneous Emphysema |
| D012507 | Sarcoidosis |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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