Imaging Measures of Respiratory Health Registry

Recruiting

• Conditions: Respiratory Disease; Healthy
• Interventions: Diagnostic Test: 1H and Xe-129 MRI

• Registration Number: NCT05102825
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-11
• Study First Submitted: 2021-09-27
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-29
• Last Update Submitted: 2021-10-29
• Study First Posted: 2021-11-02
• Last Update Posted: 2021-11-02
• Primary Completion: 2045-06-01
• Study Completion: 2045-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Respiratory Disease	1H and Xe-129 MRI	Any physician-diagnosed lung disease
Healthy	1H and Xe-129 MRI	Healthy control with no physician-diagnosed lung disease

Primary Outcome Measures

Name	Time	Method
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 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.
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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

British Columbia Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada