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临床试验/NCT05102825
NCT05102825招募中不适用

Imaging Measures of Respiratory Health Registry

University of British Columbia2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
2
主要终点
Structural proton (1H) MRI data

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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
  • 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.

结局指标

主要结局

Structural proton (1H) MRI data

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Rayment

Clinical Assistant Professor

University of British Columbia

研究点 (2)

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