Imaging Measures of Respiratory Health Registry

Study Overview
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Brief Summary
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This is a prospective, observational cohort registry that aims to collect data on pulmonary structure and function in healthy people and those with respiratory disease, using structural and functional pulmonary 1H-MRI and hyperpolarized 129Xe-MRI. Outcome measures generated from MRI may include but are not limited to measures of regional ventilation, pulmonary microarchitecture, and regional gas exchange. Additionally, one of the goals of the registry is to facilitate the development of novel image analysis techniques that have not yet been invented. These data will be stored along with demographic data, clinical data, and pulmonary function testing (PFT) data. This is an open registry. Eligible local and international investigators/institutions can apply for access.

Official Title
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Imaging Measures of Respiratory Health Registry

Conditions
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Respiratory Disease, Healthy

Intervention / Treatment
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* Diagnostic Test: 1H and Xe-129 MRI


Participation Criteria
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Eligibility Criteria
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Respiratory Disease Inclusion Criteria: Physician-diagnosed lung disease - based on a diagnosis made by a treating staff physician and confirmed by the principal investigator. Age 0-99 years. Informed consent by participant, parent, or legal guardian In the opinion of the Investigator, the participant will likely be able to perform maneuvers to obtain technically acceptable pulmonary XeMRI images. Exclusion Criteria: Physical findings at screening that, in the opinion of the Investigator, would compromise the safety of the participant or the quality of the research data. Requirement of supplementary oxygen to maintain an oxygen saturation above 95%. Failed MRI screening form. History of claustrophobia. Known current pregnancy or lactation. Healthy Inclusion Criteria: Age 0-99 years Informed consent by participant, parent, or legal guardian In the opinion of the Investigator, the participant will likely be able to perform maneuvers to obtain technically acceptable pulmonary MRI images. Exclusion Criteria Physician-diagnosed lung disease. Failed MRI screening form. History of claustrophobia. Physical findings at screening that, in the opinion of the Investigator, would compromise the safety of the participant or the quality of the research data. Known current pregnancy or lactation.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Respiratory Disease<br>Any physician-diagnosed lung disease | Diagnostic Test: 1H and Xe-129 MRI<br>* Traditional 1H-MRI (room air inhalation) and Xe-129 MRI (requires inhalation of Xenon 129 gas).<br>|
| Healthy<br>Healthy control with no physician-diagnosed lung disease | Diagnostic Test: 1H and Xe-129 MRI<br>* Traditional 1H-MRI (room air inhalation) and Xe-129 MRI (requires inhalation of Xenon 129 gas).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structural proton (1H) MRI data | Includes all proton MRI images collected to assess pulmonary structure. Data may be analysed qualitatively and quantitatively. | no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years | 
| Functional proton (1H) MRI data | Includes all proton MRI images collected to assess pulmonary function. Data may be analysed qualitatively and quantitatively. | no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years | 
| Functional hyperpolarized 129-xenon (129Xe) MRI data | Includes all proton images collected to assess pulmonary function. Data may be analysed qualitatively and quantitatively. | no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting oxygen saturation |  | no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years | 
| CFQ-R Respiratory domain | Only for participants with cystic fibrosis | no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years | 
| St. George Respiratory Questionnaire | Only for participants with Respiratory disease. | no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years |