Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT05102825

Conditions

Respiratory Disease

Healthy

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Interventions

1H and Xe-129 MRI

Study Details

Brief 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.

Conditions

Respiratory Disease

Healthy

Study ID

NCT05102825

Start date

Jun 11, 2020

Status verified date

Oct, 2021

Completion date

Jun 1, 2045

Anticipated

Primary completion date

Jun 1, 2045

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Respiratory Disease

Any physician-diagnosed lung disease

Healthy

Healthy control with no physician-diagnosed lung disease

Interventions

1H and Xe-129 MRI

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Principal Investigator:

Jonathan Rayment, MDCM, MSc

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

More Information

Sponsor

University of British Columbia

Last update posted

Nov 2, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2021-11-02.