AsthmaPhase 1NCT04624490
Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
A Phase 1 study testing Hyperpolarized Xe129 in people with Asthma and COPD, run by Mario Castro, MD, MPH at 1 site in United States.
Trial summary
The purpose of this study is to develop and evaluate the usefulness of hyperpolarized (HP) 129Xe gas MRI for regional assessment of pulmonary function. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, COPD, Interstitial Lung Disease
- What is being tested?
- Hyperpolarized Xe129
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 26 Oct 2028
- Phase
- Phase 1
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy Volunteers:
- Subject has no diagnosed pulmonary conditions
- Ability to read and understand English or Spanish
- Subjects with Lung Disease:
- Subject has a diagnosis of pulmonary dysfunction made by a physician
- No acute worsening of pulmonary function in the past 30 days
- Ability to read and understand English or Spanish
Who cannot join
- MRI is contraindicated based on responses to MRI screening questionnaire
- Subject is pregnant or lactating
- Subject does not fit into 129Xe vest coil used for MRI
- Subject cannot hold his/her breath for 15-16 seconds
- Subject deemed unlikely to be able to comply with instructions during imaging
- Oxygen saturation <88% on room air or with supplemental oxygen
- Cognitive deficits that preclude ability to provide consent
- Institutionalization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Peter J Niedbalski, PhD, 9135882271, pniedbalski@kumc.edu
About this study
The purpose of this study is to develop and evaluate the usefulness of hyperpolarized (HP) 129Xe gas MRI for regional assessment of pulmonary function.
Read the detailed description
This is an unblinded, open-label study with ~160 subjects with diagnosed pulmonary disease and ~100 healthy controls. Subjects to be enrolled will include males and females 18-80 years old. Evaluation will be on an outpatient basis. Imaging will be done on a single day and will involve administration of up to four 1-liter doses of HP 129Xe plus one 129Xe calibration dose (~300-400mL HP 129Xe). In addition to 129Xe MRI, a series of anatomical conventional 1H MR images will be collected including a localizer scan, breath-hold spin echo image, and breath-hold steady-state free precession image to highlight the vasculature. All subjects will be evaluated at one center: The University of Kansas Medical Center, KS USA.
- Conditions
- Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis, Pulmonary Hypertension, Pulmonary Infection
- Being tested
- Hyperpolarized Xe129
- Keywords
- Hyperpolarized 129Xe MRI
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Cystic Fibrosis, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Xe129Drug
Also called HP Xenon
During MRI scanning, subject will inhale hyperpolarized xenon gas for a maximum of 16 seconds per scan, with a maximum of 4 MR scans + Calibration in a given imaging session.
| Study group | Role | What they receive |
|---|---|---|
| Hyperpolarized 129Xe | Experimental | Administration of hyperpolarized xenon during MRI (up to 1L doses) to develop imaging methods and assess pulmonary function in adults. Receives: Drug: Hyperpolarized Xe129 |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBC/Barrier Ratio
Ratio of xenon signal dissolved in RBCs to xenon signal dissolved in Barrier Tissues
Measured: Day 1
Secondary outcomes (2)
ADC
Apparent Diffusion Coefficient of Xenon Gas in the lungs
Measured: Day 1
Ventilation Defect Percentage
Percentage of the Lungs with ventilation signal below a threshold level
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start2 Nov 2020
- Primary completion26 Oct 2028 (estimated)
- Study completion26 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mario Castro, MD, MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mario Castro, MD, MPH, University of Kansas Medical Center
- Investigators
- Peter Niedbalski, PHD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624490
- Sponsor's protocol ID
- STUDY00146119
- Status last verified
- Apr 2026
- First submitted
- 31 Oct 2020
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04624490
- Acronym / sponsor ID
- STUDY00146119
- Conditions
- Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis, Pulmonary Hypertension, Pulmonary Infection
- Keywords
- Hyperpolarized 129Xe MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Mario Castro, MD, MPHUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 26 Oct 2028 (estimated)
- Study completion
- 26 Oct 2028 (estimated)
- First posted
- 10 Nov 2020 (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.
The purpose of this study is to develop and evaluate the usefulness of hyperpolarized (HP) 129Xe gas MRI for regional assessment of pulmonary function.
Detailed description
This is an unblinded, open-label study with ~160 subjects with diagnosed pulmonary disease and ~100 healthy controls. Subjects to be enrolled will include males and females 18-80 years old. Evaluation will be on an outpatient basis. Imaging will be done on a single day and will involve administration of up to four 1-liter doses of HP 129Xe plus one 129Xe calibration dose (~300-400mL HP 129Xe). In addition to 129Xe MRI, a series of anatomical conventional 1H MR images will be collected including a localizer scan, breath-hold spin echo image, and breath-hold steady-state free precession image to highlight the vasculature. All subjects will be evaluated at one center: The University of Kansas Medical Center, KS USA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperpolarized 129Xe | Experimental | Drug: Hyperpolarized Xe129Administration of hyperpolarized xenon during MRI (up to 1L doses) to develop imaging methods and assess pulmonary function in adults. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has no diagnosed pulmonary conditions
- Ability to read and understand English or Spanish
- Subject has a diagnosis of pulmonary dysfunction made by a physician
- No acute worsening of pulmonary function in the past 30 days
- Ability to read and understand English or Spanish
Key exclusion criteria (8 listed)
- MRI is contraindicated based on responses to MRI screening questionnaire
- Subject is pregnant or lactating
- Subject does not fit into 129Xe vest coil used for MRI
- Subject cannot hold his/her breath for 15-16 seconds
- Subject deemed unlikely to be able to comply with instructions during imaging
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 Xe129Also: HP XenonDuring MRI scanning, subject will inhale hyperpolarized xenon gas for a maximum of 16 seconds per scan, with a maximum of 4 MR scans + Calibration in a given imaging session. | Drug | Hyperpolarized 129Xe |
Primary outcome
RBC/Barrier Ratio
Time frame: Day 1
Ratio of xenon signal dissolved in RBCs to xenon signal dissolved in Barrier Tissues
2 secondary outcomes
ADC
Time frame: Day 1
Ventilation Defect Percentage
Time frame: Day 1
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 6 May 2026.
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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.
Peter Niedbalski, PHD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyperpolarized Xe129 in people with Asthma and COPD, run by Mario Castro, MD, MPH at 1 site in United States.
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 8 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: looking for participants now, as of the sponsor's last update on 6 May 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Cristal Monge (913-945-9399, chernandez@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RBC/Barrier Ratio (time frame: Day 1). 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 6 May 2026.