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Clinical Trials/NCT05102825
NCT05102825
Recruiting
Not Applicable

Imaging Measures of Respiratory Health Registry

University of British Columbia2 sites in 1 country1,000 target enrollmentJune 11, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Disease
Sponsor
University of British Columbia
Enrollment
1000
Locations
2
Primary Endpoint
Structural proton (1H) MRI data
Status
Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 11, 2020
End Date
June 1, 2045
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jonathan Rayment

Clinical Assistant Professor

University of British Columbia

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria

Outcomes

Primary Outcomes

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 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.

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.

Secondary Outcomes

  • 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)
  • Resting oxygen saturation(no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years)

Study Sites (2)

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