Healthy Volunteers - Male and FemaleNCT07533981
¹²⁹Xe(XENON) MRI Program
A study testing Hyperpolarized Xenon MRI in people with Healthy Volunteers - Male and Female, run by Alexei Ouriadov at 1 site in Canada.
Trial summary
Healthy volunteers aged 18 to 85 will undergo hyperpolarized Xenon-129 (¹²⁹Xe) MRI and pulmonary function testing. The study aims to develop evaluation tools for ventilation defect percent (VDP), signal-to-noise and contrast-to-noise ratios (SNR/CNR) of ¹²⁹Xe dissolved-phase images, and spectroscopy-based analysis. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers - Male and Female
- What is being tested?
- Hyperpolarized Xenon MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2026to 30 Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient understands study procedures and is willing to participate in the study as indicated by the patient's signature.
- Provision of written, informed consent prior to any study specific procedures.
- Males and females aged 18 to 85 years.
- Participant must be able to perform a breath-hold for 16s.
- Participant has a BMI between 18 and 40
- Participant must be able to perform reproducible pulmonary function tests (i.e., the 3 best acceptable spirograms have forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater)
- Participants are judged to be in stable health on the basis of medical history
Who cannot join
- Patient has an MR incompatible implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist).
- In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI or CT, such as severe claustrophobia.
- Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit.
- Participant is unable to perform spirometry maneuvers.
- Participant is unable to perform MRI and CT breath-hold maneuvers.
- Participant has a history of chronic or acute respiratory disease
Show all 9Show fewer
- FEV1 <70%
- Participant has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension (≥160 over ≥100)
- Participant has a daytime room air oxygen saturation ≤ 92% ± 2% while supine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tommy Li, Msc contact
Canada1 site
St Joseph's Healthcare London
London, Ontario, N6A 4V2
Hana Serajeddini, MD, FRCPC, (519) 646-6100 ext. 66288, hana.serajeddini@lhsc.on.ca
Tommy Li, zli3569@uwo.ca
About this study
Official title: HARDWARE AND SOFTWARE DEVELOPMENT FOR PULMONARY MAGNETIC RESONANCE IMAGING USING INHALED INERT HYPERPOLARIZED ¹²⁹XENON GAS
Healthy volunteers aged 18 to 85 will undergo hyperpolarized Xenon-129 (¹²⁹Xe) MRI and pulmonary function testing. The study aims to develop evaluation tools for ventilation defect percent (VDP), signal-to-noise and contrast-to-noise ratios (SNR/CNR) of ¹²⁹Xe dissolved-phase images, and spectroscopy-based analysis.
Read the detailed description
Briefly, during a one hour visit, subjects will provide written informed consent and then undergo:
- brief medical history and vital signs,
- full pulmonary function tests,
- proton MRI,
- spin-density, diffusion weighted, and/or dissolved phase 129-Xe MRI, Full pulmonary function tests including spirometry and FeNO test according to American Thoracic Society (ATS) guidelines.
Subjects will be placed in the 3T Magnetic Resonance (MR) scanner with one 129-Xe chest coil fitted over their torso and chest. Hearing protection will be provided to each subject to muffle the noise produced by the gradient radiofrequency (RF) coils. A pulse oximeter lead will be attached to all of the subjects to monitor their heart rate and oxygen saturation. MRI will be performed for up to a period of 30 minutes. All subjects will have supplemental oxygen available via nasal cannula at a flow-rate of 2 liters per minute as a precaution in the event of oxygen desaturation.
- Conditions
- Healthy Volunteers - Male and Female
- Being tested
- Hyperpolarized Xenon MRI
- Keywords
- 129 Xe MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Xenon MRIDevice
Hyperpolarized noble gas imaging using Xenon-129 has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI imaging, 129Xe gas is used as a contrast agent to directly visualize the airways, and thus ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping.
| Study group | Role | What they receive |
|---|---|---|
| Hyperpolarized Xenon MRI | Experimental | Participants will undergo pulmonary function tests, 129 Xenon MRI at the visit. Receives: Device: Hyperpolarized Xenon MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal-to-noise ratio (SNR)
A quantitative measure of image quality that compares the level of the desired signal to the background noise in an MRI image.
Measured: 5 years
Contrast-to-noise ratio (CNR)
A measure of how well different tissues or structures can be distinguished from each other in an image relative to background noise.
Measured: 5 years
Image spatial resolution
The primary endpoints are to assess the necessary imaging sequences, reconstruction algorithms, and hardware to acquire high spatial resolution lung images from MRI. Image spatial resolution (mm) is the ability of the imaging system to distinguish small structures, expressed as the smallest detectable detail in millimeters.
Measured: 5 years
Scan duration (minutes)
The total time required to complete the imaging acquisition for the protocol, measured in minutes.
Measured: 5 years
Secondary outcomes (1)
Ventilation Defect Percent (VDP) of the lung
VDP is a widely used noble gas MRI biomarkers that is calculated by normalizing ventilation defect volume to the thoracic cavity.
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 posted16 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers - Male and FemaleStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Device: Hyperpolarized Xenon MRI
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexei Ouriadov
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Health Care London
- Responsible party
- Sponsor-investigator, Alexei Ouriadov, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533981
- Sponsor's protocol ID
- SJHC0002
- Status last verified
- Jul 2025
- First submitted
- 2 Feb 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified individual participant data supporting the results will be shared beginning 9 months after publication, available for up to 5 years. Access is open to researchers with approved proposals, subject to a data use agreement. Data will be shared via a secure platform upon approval
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HARDWARE AND SOFTWARE DEVELOPMENT FOR PULMONARY MAGNETIC RESONANCE IMAGING USING INHALED INERT HYPERPOLARIZED ¹²⁹XENON GAS
- ClinicalTrials.gov ID
- NCT07533981
- Acronym / sponsor ID
- SJHC0002
- Conditions
- Healthy Volunteers - Male and Female
- Keywords
- 129 Xe MRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Alexei OuriadovUniversity, hospital or other
- Collaborators
- St. Joseph's Health Care London
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Apr 2031 (estimated)
- First posted
- 16 Apr 2026 (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.
Healthy volunteers aged 18 to 85 will undergo hyperpolarized Xenon-129 (¹²⁹Xe) MRI and pulmonary function testing. The study aims to develop evaluation tools for ventilation defect percent (VDP), signal-to-noise and contrast-to-noise ratios (SNR/CNR) of ¹²⁹Xe dissolved-phase images, and spectroscopy-based analysis.
Detailed description
Briefly, during a one hour visit, subjects will provide written informed consent and then undergo:
- brief medical history and vital signs,
- full pulmonary function tests,
- proton MRI,
- spin-density, diffusion weighted, and/or dissolved phase 129-Xe MRI, Full pulmonary function tests including spirometry and FeNO test according to American Thoracic Society (ATS) guidelines.
Subjects will be placed in the 3T Magnetic Resonance (MR) scanner with one 129-Xe chest coil fitted over their torso and chest. Hearing protection will be provided to each subject to muffle the noise produced by the gradient radiofrequency (RF) coils. A pulse oximeter lead will be attached to all of the subjects to monitor their heart rate and oxygen saturation. MRI will be performed for up to a period of 30 minutes. All subjects will have supplemental oxygen available via nasal cannula at a flow-rate of 2 liters per minute as a precaution in the event of oxygen desaturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Device: Hyperpolarized Xenon MRI
| Arm | Type | Receives |
|---|---|---|
| Hyperpolarized Xenon MRI | Experimental | Device: Hyperpolarized Xenon MRIParticipants will undergo pulmonary function tests, 129 Xenon MRI at the visit. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient understands study procedures and is willing to participate in the study as indicated by the patient's signature.
- Provision of written, informed consent prior to any study specific procedures.
- Males and females aged 18 to 85 years.
- Participant must be able to perform a breath-hold for 16s.
- Participant has a BMI between 18 and 40
Key exclusion criteria (9 listed)
- Patient has an MR incompatible implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist).
- In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI or CT, such as severe claustrophobia.
- Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit.
- Participant is unable to perform spirometry maneuvers.
- Participant is unable to perform MRI and CT breath-hold maneuvers.
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 Xenon MRIHyperpolarized noble gas imaging using Xenon-129 has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI imaging, 129Xe gas is used as a contrast agent to directly visualize the airways, and thus ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping. | Device | Hyperpolarized Xenon MRI |
Primary outcome
Signal-to-noise ratio (SNR)
Time frame: 5 years
A quantitative measure of image quality that compares the level of the desired signal to the background noise in an MRI image.
Contrast-to-noise ratio (CNR)
Time frame: 5 years
A measure of how well different tissues or structures can be distinguished from each other in an image relative to background noise.
Image spatial resolution
Time frame: 5 years
The primary endpoints are to assess the necessary imaging sequences, reconstruction algorithms, and hardware to acquire high spatial resolution lung images from MRI. Image spatial resolution (mm) is the ability of the imaging system to distinguish small structures, expressed as the smallest detectable detail in millimeters.
Scan duration (minutes)
Time frame: 5 years
The total time required to complete the imaging acquisition for the protocol, measured in minutes.
1 secondary outcome
Ventilation Defect Percent (VDP) of the lung
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Undecided. Deidentified individual participant data supporting the results will be shared beginning 9 months after publication, available for up to 5 years. Access is open to researchers with approved proposals, subject to a data use agreement. Data will be shared via a secure platform upon approval
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Healthy Participants
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.
Tommy Li, Msc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperpolarized Xenon MRI in people with Healthy Volunteers - Male and Female, run by Alexei Ouriadov 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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 16 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hana Serajeddini, MD, FRCPC ((519) 646-6100 ext. 66288, hana.serajeddini@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal-to-noise ratio (SNR) (time frame: 5 years). The study lists 4 primary outcomes in all. 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 16 Apr 2026.