Imaging Measures of Respiratory Health Registry

Healthy Clinical Trial

— iMRH  

Official title:

Imaging Measures of Respiratory Health Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05102825
• Other study ID #: H19-01163
• Status: Recruiting
• Start date: June 11, 2020
• Est. completion date: June 1, 2045

Study information

• Verified date: October 2021
• Source: University of British Columbia
• Contact: Rodrigo Sandoval, MSc
• Phone: 6048752345
• Email: Rodrigo.Sandoval[@]bcchr.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2045
• Est. primary completion date: June 1, 2045
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Resting oxygen saturation		no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years
Secondary	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
Secondary	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