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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04726618
Other study ID # 1000070140
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date February 15, 2026

Study information

Verified date May 2022
Source The Hospital for Sick Children
Contact Giles Santyr, PhD
Phone 416-813-7654
Email giles.santyr@sickkids.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date February 15, 2026
Est. primary completion date February 15, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 75 Years
Eligibility 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*

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hyperpolarized 129-xenon gas and Perfluoropropane gas
Hyperpolarized 129-xenon gas will be used as a contrast agent for MRI. Xenon will be inhaled by the participant at a maximum dose volume of 1/6 of the participant's total lung capacity. Perfluoropropane will also be used as a contrast agent for MRI. Perfluoropropane will be inhaled as a normoxic mixture (21% O2 and 79% perfluoropropane).

Locations

Country Name City State
Canada Hospital for Sick Children Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. This objective will initially begin with preliminary work to demonstrate the ability to acquire in vivo 129Xe and/or 19F MR images in participants with no history of respiratory disease. This study will also focus on the advancement of MR imaging hardware and software to optimize image acquisition and reconstruction. Imaging capability will be evaluated on the basis of image quality, signal-to-noise ratio, contrast-to-noise ratio, image resolution, and scan duration. We will also explore new methods of generating image contrast with these gases. 5 years
Secondary Comparison of 19F MRI to HP 129Xe MRI 19F MRI and HP 129Xe MRI are both inhaled tracer gases for MR imaging of lung function. In this study we aim to demonstrate 19F imaging and compare image quality against HP 129Xe in adults and children. 5 years
Secondary Evaluation of intra and inter-scan reproducibility Repeat measurements will be performed within the study visit to evaluate intra-scan reproducibility. Additionally, repeat measures will be performed in participants during subsequent visits on different days to quantify inter-scan repeatability of imaging measures developed in this study. 5 years
Secondary Comparison of MR imaging to pulmonary function testing The imaging measures developed in this study will be compared to pulmonary function tests which are considered the clinical gold standard for measuring lung function. 5 years
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