Clinical trial NCT05102825: Imaging Measures of Respiratory Health Registry
Official title: Imaging Measures of Respiratory Health Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Disease
Healthy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Structural proton (1H) MRI data
timeFrame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years
measure: Functional proton (1H) MRI data
timeFrame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years
measure: Functional hyperpolarized 129-xenon (129Xe) MRI data
timeFrame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years
Secondary outcomes:
measure: Resting oxygen saturation
timeFrame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years
measure: CFQ-R Respiratory domain
timeFrame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years
measure: St. George Respiratory Questionnaire
timeFrame: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jonathan Rayment, MDCM, MSc
role: PRINCIPAL_INVESTIGATOR
References: