Imaging Measures of Respiratory Health Registry

Обзор

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.

Вмешательства

• Диагностический тест 1H and Xe-129 MRI
  Traditional 1H-MRI (room air inhalation) and Xe-129 MRI (requires inhalation of Xenon 129 gas).

Первичные конечные точки

• Structural proton (1H) MRI data [Срок оценки: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years]
• Functional proton (1H) MRI data [Срок оценки: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years]
• Functional hyperpolarized 129-xenon (129Xe) MRI data [Срок оценки: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years]

Вторичные конечные точки (3)

• Resting oxygen saturation [Срок оценки: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years]
• CFQ-R Respiratory domain [Срок оценки: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years]
• St. George Respiratory Questionnaire [Срок оценки: no predefined schedule in this open registry study; maximum 25 visits, over up to 25 years]

Критерии участия

Respiratory Disease

Критерии включения

• 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.

Критерии исключения

• 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

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 2 центра

• British Columbia Children's Hospital — Vancouver
• St. Paul's Hospital — Vancouver

Идентификаторы

NCT: NCT05102825 · H19-01163

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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