Menu
Recruiting NCT05102825

Imaging Measures of Respiratory Health Registry

— Observational Respiratory Disease Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 1H and Xe-129 MRI.
Who it may be relevant to
Registry conditions: Respiratory Disease, Healthy. Basic parameters: 0 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Structural proton (1H) MRI data [Time frame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years]
  • Functional proton (1H) MRI data [Time frame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years]
  • Functional hyperpolarized 129-xenon (129Xe) MRI data [Time frame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years]
Secondary outcome measures (3)
  • Resting oxygen saturation [Time frame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years]
  • CFQ-R Respiratory domain [Time frame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years]
  • St. George Respiratory Questionnaire [Time frame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Canada · 2 centers
  • British Columbia Children's Hospital — Vancouver
  • St. Paul's Hospital — Vancouver

Identifiers

NCT: NCT05102825 · H19-01163

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗