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NCT Number: NCT05102825

Imaging Measures of Respiratory Health Registry

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.

Recruiting

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Key information

Conditions

Respiratory Disease Healthy Respiration Disorders Respiratory Tract Diseases

Age range

0 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

British Columbia Children's Hospital, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1H and Xe-129 MRI

Diagnostic Test

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

Primary outcomes

  1. Structural proton (1H) MRI data

    Time frame: 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.

  2. Functional proton (1H) MRI data

    Time frame: 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.

  3. 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

    Includes all proton images collected to assess pulmonary function. Data may be analysed qualitatively and quantitatively.

Secondary outcomes

  1. Resting oxygen saturation

    Time frame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years

  2. CFQ-R Respiratory domain

    Time frame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years

    Only for participants with cystic fibrosis

  3. St. George Respiratory Questionnaire

    Time frame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years

    Only for participants with Respiratory disease.

Study contacts

Contact information is provided by the study sponsor or research team.

Rodrigo Sandoval, MSc

CONTACT

[email protected]

6048752345 ext. 2928

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Acronym: iMRH

Important dates

Study start
2020
Primary completion
2045
Study completion
2045
First posted
Nov 2, 2021
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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