Clinical trial NCT04726618: Development of Hardware and Software for Pulmonary Magnetic Resonance Imaging Using Inhaled Tracer Gases
Official title: Development of Hardware and Software for Pulmonary Magnetic Resonance Imaging Using Inhaled Tracer Gases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Volunteers
Keywords: Lung MRI
Healthy
HP Xenon gas
Perfluoropropane gas
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 male and females aged 6-75 with no history of respiratory disease will be used for this study.

Brief summary: This is a single centre study. The overarching hypothesis of this study is that MRI with inhaled tracer gases can provide high quality images of lung function to complement conventional 1H MRI. The study interventions do not affect the standard of care.

Detailed description: Respiratory diseases are a significant healthcare burden worldwide. In Canada, this is expected to increase. Non-invasive medical imaging tests are able to provide regional functional and structural information of the lung and may aid in the diagnosis and treatment of respiratory diseases. Current examples include chest x-ray, x-ray computed tomography (CT), and nuclear medicine techniques. However, these techniques suffer from various associated limitations. X-ray based methods offer high resolution and rapid acquisitions, but only reflect lung structure and anatomy by measuring tissue density. Nuclear medicine techniques may be used to measure lung function but suffer from poor resolution and long acquisition times. Furthermore, both x-ray based and nuclear medicine imaging techniques make use of ionizing radiation, which may not be suitable for longitudinal imaging, or imaging in vulnerable populations such as children.

Conventional Magnetic Resonance Imaging (MRI) images the 1H nucleus (proton) attached to water molecules in biological tissues. MRI can provide high-resolution anatomical and functional information of the lung with multiparametric contrast without the use of ionizing radiation. However, major drawbacks associated with conventional 1H MRI of the lung are the low tissue density, large magnetic susceptibility differences between numerous air/tissue interfaces, and image corruption by cardiorespiratory motion during the necessarily long image acquisition time frame. Wo;;

One strategy which may be employed to overcome the limitations associated with conventional 1H MRI is the application of safe MR-sensitive inhaled tracer gases. This allows for the direct visualization of the spatial distribution of these gases, revealing regional ventilation directly. In this study we aim to develop, implement, and test these technologies for improved in-vivo imaging of lung structure and function in adults and children with no history of respiratory disease.

Eligibility criteria: Inclusion Criteria:

* Consent provided
* Aged 6-75 years old
* In good general health as evidenced by medical history
* Meets MRI screening criteria

Exclusion Criteria:

* Has diagnosis of pulmonary disease
* FEV1 \<70%
* Requires supplemental oxygen
* Has had a respiratory infection within the past 2 weeks
* Pregnant or lactating\*

Primary outcomes:
measure: The primary objective of this study is to develop the necessary imaging sequences, reconstruction algorithms, and hardware to acquire high quality lung images using HP 129Xe, 19F MRI, and conventional 1H MRI.
timeFrame: 5 years
Secondary outcomes:
measure: Comparison of 19F MRI to HP 129Xe MRI
timeFrame: 5 years
measure: Evaluation of intra and inter-scan reproducibility
timeFrame: 5 years
measure: Comparison of MR imaging to pulmonary function testing
timeFrame: 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Giles Santyr, PhD
role: PRINCIPAL_INVESTIGATOR
References: