Imaging Measures of Respiratory Health Registry (iMRH)

October 29, 2021 updated by: Jonathan Rayment, University of British Columbia

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
        • Contact:
        • Principal Investigator:
          • Jonathan Rayment, MDCM, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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
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.
no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resting oxygen saturation
Time Frame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years
no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years
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
no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years
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.
no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan Rayment, MDCM, MSc, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2045

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2045

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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