Healthy VolunteersNCT04726618
Development of Hardware and Software for Pulmonary Magnetic Resonance Imaging Using Inhaled Tracer Gases
An observational study of Healthy Volunteers, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 6 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Hyperpolarized 129-xenon gas and Perfluoropropane gas
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2022to 9 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 50 male and females aged 6-75 with no history of respiratory disease will be used for this study.
Who may be able to join
- Consent provided
- Aged 6-75 years old
- In good general health as evidenced by medical history
- Meets MRI screening criteria
Who cannot join
- Has diagnosis of pulmonary disease
- FEV1 <70%
- Requires supplemental oxygen
- Has had a respiratory infection within the past 2 weeks
- Pregnant or lactating*
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Hyperpolarized 129-xenon gas and Perfluoropropane gas
- Keywords
- Lung MRI, Healthy, HP Xenon gas, Perfluoropropane gas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 129-xenon gas and Perfluoropropane gasDrug
Also called Tracer Gases
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (3)
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Mar 2022
- Primary completion9 Apr 2024
- Study completion9 Apr 2024
Why it stopped: Funding constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giles Santyr, The Hospital for Sick Children
- Investigators
- Giles Santyr, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726618
- Sponsor's protocol ID
- 1000070140
- Status last verified
- Aug 2025
- First submitted
- 22 Jan 2021
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Hardware and Software for Pulmonary Magnetic Resonance Imaging Using Inhaled Tracer Gases
- ClinicalTrials.gov ID
- NCT04726618
- Acronym / sponsor ID
- 1000070140
- Conditions
- Healthy Volunteers
- Keywords
- Lung MRI, Healthy, HP Xenon gas, Perfluoropropane gas
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding constraints
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 50 male and females aged 6-75 with no history of respiratory disease will be used for this study.
Key inclusion criteria (4 listed)
- Consent provided
- Aged 6-75 years old
- In good general health as evidenced by medical history
- Meets MRI screening criteria
Key exclusion criteria (5 listed)
- Has diagnosis of pulmonary disease
- FEV1 <70%
- Requires supplemental oxygen
- Has had a respiratory infection within the past 2 weeks
- Pregnant or lactating*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized 129-xenon gas and Perfluoropropane gasAlso: Tracer GasesHyperpolarized 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). | Drug | – |
Primary outcome
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.
Time frame: 5 years
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.
3 secondary outcomes
Comparison of 19F MRI to HP 129Xe MRI
Time frame: 5 years
Evaluation of intra and inter-scan reproducibility
Time frame: 5 years
Comparison of MR imaging to pulmonary function testing
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Funding constraints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giles Santyr, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding constraints). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.