NCT05102825

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
232mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Jun 2020Jun 2045

Study Start

First participant enrolled

June 11, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
23.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2045

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2045

Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

25 years

First QC Date

September 27, 2021

Last Update Submit

October 29, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Resting oxygen saturation

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

  • CFQ-R Respiratory domain

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

  • St. George Respiratory Questionnaire

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

Study Arms (2)

Respiratory Disease

Any physician-diagnosed lung disease

Diagnostic Test: 1H and Xe-129 MRI

Healthy

Healthy control with no physician-diagnosed lung disease

Diagnostic Test: 1H and Xe-129 MRI

Interventions

1H and Xe-129 MRIDIAGNOSTIC_TEST

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

HealthyRespiratory Disease

Eligibility Criteria

Age0 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Jonathan Rayment, MDCM, MSc

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo Sandoval, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

September 27, 2021

First Posted

November 2, 2021

Study Start

June 11, 2020

Primary Completion (Estimated)

June 1, 2045

Study Completion (Estimated)

June 1, 2045

Last Updated

November 2, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

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.

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.

Locations