Imaging Measures of Respiratory Health Registry

NCT05102825 · tracked via the Priya Life Science Canada tracker

Sponsor

University of British Columbia

Phase

Observational

Started

2020-06-11

Last updated

2021-11-02

Condition(s) studied

Respiratory DiseaseHealthy

Investigational drug(s) / intervention(s)

1H and Xe-129 MRI

1H and Xe-129 MRI: Traditional 1H-MRI (room air inhalation) and Xe-129 MRI (requires inhalation of Xenon 129 gas).

Study summary

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.

Eligibility

Sex

ALL

Min age

0 Years

Max age

99 Years

Healthy volunteers

Accepted

Respiratory Disease Inclusion Criteria: 1. Physician-diagnosed lung disease - based on a diagnosis made by a treating staff physician and confirmed by the principal investigator. 2. Age 0-99 years. 3. Informed consent by participant, parent, or legal guardian 4. In the opinion of the Investigator, the participant will likely be able to perform maneuvers to obtain technically acceptable pulmonary XeMRI images. Exclusion Criteria: 1. 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. 2. Requirement of supplementary oxygen to maintain an oxygen saturation above 95%. 3. Failed MRI screening form. 4. History of claustrophobia. 5. Known current pregnancy or lactation. Healthy Inclusion Criteria: 1. Age 0-99 years 2. Informed consent by participant, parent, or legal guardian 3. In the opinion of the Investigator, the participant will likely be able to perform maneuvers to obtain technically acceptable pulmonary MRI images. Exclusion Criteria 1. Physician-diagnosed lung disease. 2. Failed MRI screening form. 3. History of claustrophobia. 4. 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. 5. Known current pregnancy or lactation.

Primary outcome measure(s)

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

Trial sites (2)

Facility	City	Region	Status
British Columbia Children's Hospital	Vancouver	British Columbia	Recruiting
St. Paul's Hospital	Vancouver	British Columbia	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05102825 on ClinicalTrials.gov ↗ ← All trials in Canada