Respiratory DiseaseiMRHNCT05102825
Imaging Measures of Respiratory Health Registry
An observational study of Respiratory Disease and Healthy, run by University of British Columbia at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disease, Healthy
- What is being tested?
- 1H and Xe-129 MRI
- How many people
- 1,000 participants
- Where
- 2 sitesCanada
- Study dates
- 11 Jun 2020to 1 Jun 2045
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3N1
Rodrigo Sandoval, MSc, 6048752345 ext. 2928, Rodrigo.Sandoval@bcchr.ca
Alam Lakhani, 6048752345 ext. 7606, alam.lakhani@cw.bc.ca
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Don Sin, MD MPH
About this study
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.
Read more
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
- Being tested
- 1H and Xe-129 MRI
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1H and Xe-129 MRIDiagnostic test
Traditional 1H-MRI (room air inhalation) and Xe-129 MRI (requires inhalation of Xenon 129 gas).
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Disease | Any physician-diagnosed lung disease Receives: Diagnostic Test: 1H and Xe-129 MRI | |
| Healthy | Healthy control with no physician-diagnosed lung disease Receives: Diagnostic Test: 1H and Xe-129 MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural proton (1H) MRI data
Includes all proton MRI images collected to assess pulmonary structure. Data may be analysed qualitatively and quantitatively.
Measured: 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.
Measured: 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.
Measured: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years
Secondary outcomes (3)
Resting oxygen saturation
Measured: 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
Measured: 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.
Measured: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start11 Jun 2020
- Primary completion1 Jun 2045 (estimated)
- Study completion1 Jun 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Rayment, University of British Columbia
- Investigators
- Jonathan Rayment, MDCM, MSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102825
- Sponsor's protocol ID
- H19-01163
- Acronym
- iMRH
- Status last verified
- Oct 2021
- First submitted
- 27 Sep 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Measures of Respiratory Health Registry
- ClinicalTrials.gov ID
- NCT05102825
- Acronym / sponsor ID
- iMRH / H19-01163
- Conditions
- Respiratory Disease, Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 1 Jun 2045 (estimated)
- Study completion
- 1 Jun 2045 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory Disease | – | Diagnostic Test: 1H and Xe-129 MRIAny physician-diagnosed lung disease |
| Healthy | – | Diagnostic Test: 1H and Xe-129 MRIHealthy control with no physician-diagnosed lung disease |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
- Age 0-99 years
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1H and Xe-129 MRITraditional 1H-MRI (room air inhalation) and Xe-129 MRI (requires inhalation of Xenon 129 gas). | Diagnostic test | Healthy, Respiratory Disease |
Primary outcome
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.
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.
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.
3 secondary outcomes
Resting oxygen saturation
Time frame: 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
St. George Respiratory Questionnaire
Time frame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Rayment, MDCM, MSc principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease and Healthy, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo Sandoval, MSc (6048752345 ext. 2928, Rodrigo.Sandoval@bcchr.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.