Healthy Volunteers Clinical Trial
Official title:
Development of Hardware and Software for Pulmonary Magnetic Resonance Imaging Using Inhaled Tracer Gases
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 |
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.
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* |
Country | Name | City | State |
---|---|---|---|
Canada | Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children |
Canada,
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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