Imaging Measures of Respiratory Health Registry (iMRH)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Respiratory Disease
• Intervention / Treatment: Diagnostic test: 1H and Xe-129 MRI

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Rodrigo Sandoval, MSc; Phone Number: 2928 6048752345; Email: Rodrigo.Sandoval@bcchr.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Recruiting
      • St. Paul's Hospital
      • Sub-Investigator: Don Sin, MD MPH
    • Vancouver, British Columbia, Canada, V6H 3N1
      • Recruiting
      • British Columbia Children's Hospital
      • Contact: Rodrigo Sandoval, MSc; Phone Number: 2928 6048752345; Email: Rodrigo.Sandoval@bcchr.ca
      • Contact: Alam Lakhani; Phone Number: 7606 6048752345; Email: alam.lakhani@cw.bc.ca
      • Principal Investigator: Jonathan Rayment, MDCM, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible individuals with respiratory disease will be identified from various Respiratory Medicine or subspecialty clinics at British Columbia Children's Hospital (BCCH) or from analogous clinics at St Paul's Hospital (SPH). Participants may be contacted using a First Contact Letter, or permission to approach will be obtained by a member of their circle of care.

Healthy participants will be recruited from family members of patients in the Division of Respiratory Medicine at BCCH and SPH as well as from the community or other clinics using flyers or a First Contact Letter.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Respiratory Disease; Any physician-diagnosed lung disease	Diagnostic test: 1H and Xe-129 MRI; Traditional 1H-MRI (room air inhalation) and Xe-129 MRI (requires inhalation of Xenon 129 gas).
Healthy; Healthy control with no physician-diagnosed lung disease	Diagnostic test: 1H and Xe-129 MRI; Traditional 1H-MRI (room air inhalation) and Xe-129 MRI (requires inhalation of Xenon 129 gas).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Jonathan Rayment, MDCM, MSc, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Anticipated): June 1, 2045
• Study Completion (Anticipated): June 1, 2045

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: H19-01163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: iMRH-Registry Data may be shared with investigators from BCCHR/UBC or elsewhere. iMRH-Registry Co-Investigaotrs using iMRH Registry Data to address the Scientific Objectives of the iMRH Registry do not need to formally apply for access. All other User-Investigators (domestic and international) must apply to the iMRH-Registry Data Access Committee for access to the iMRH-Registry Data.

IPD Sharing Access Criteria

Criteria for access to the iMRH-Registry Data:

1. The Proposed Study must demonstrate approval by a Qualified REB
2. The objectives of the Proposed Study must align with the scientific objectives of the iMRH-Registry (see §5)
3. Use of the iMRH Registry Data in the Proposed Study must respect the informed consent given by the participants of the iMRH Registry;
4. The Proposed Study must have scientific merit, as assessed by the iMRH Registry Data Access Committee
5. The User-Investigator must demonstrate sufficient funding to perform the Proposed Study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No