HSCTPhase 1/2NCT07823010
Technical Development of Xe MRI
A Phase 1/2 study testing Hyperpolarized 129 Xenon in people with HSCT and Lung Transplant Recipient, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The goal of this study is to develop and optimize new proton (1H; conventional MRI) and Xe gas MRI techniques to assess regional cardiopulmonary structure and function in the clinical setting. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HSCT, Lung Transplant Recipient
- What is being tested?
- Hyperpolarized 129 Xenon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to Jan 2030
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participant is having a clinically-ordered hyperpolarized Xe gas MRI scan
Who cannot join
- Pregnancy or positive pregnancy test
- Standard MRI exclusions
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
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Technical Development of Xe MRI in Children and Adults
The goal of this study is to develop and optimize new proton (1H; conventional MRI) and Xe gas MRI techniques to assess regional cardiopulmonary structure and function in the clinical setting. Specifically, three forms of Xe MRI techniques will be our focus: (1) imaging of the Xe ventilation distribution (which is the current FDA-approved indication for Xe MRI); (2) imaging the alveolar microstructure via the Xe apparent diffusion coefficient (ADC); and (3) detecting via spectroscopy and imaging Xe gas dissolved in the pulmonary blood and tissues upon inhalation.
- Conditions
- HSCT, Lung Transplant Recipient
- Being tested
- Hyperpolarized 129 Xenon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 129 XenonDrug
The total dosing volume will be consistent with CCHMC Department of Radiology clinical standards or up to 1/6th of a participant's total lung capacity (calculated or predicted from ATS guidelines or from participant's plethysmography data if available within 6 months of MRI scan) for participants under 18 years old and 1000 milliliters for adults. No more than a total of five Xe gas doses, combined clinical and research doses, will be administered during the scanning session.
| Study group | Role | What they receive |
|---|---|---|
| Hyperpolarized 129 Xenon | Experimental | This research study will happen immediately following the clinical MRI exam with additional research Xe doses administered after the clinical Xe MRI procedure. Xe gas will be administered to the participant in the same manner as the clinical Xe MRI scan. Research scans without Xe gas may be acquired as well. Receives: Drug: Hyperpolarized 129 Xenon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xenon gas Defect Distribution Index (DDI)
The signal intensity of Xe gas in a voxel (in arbitrary units) as compared to neighboring voxels, with a higher DDI indicating more clustered and focal Xe defects.
Measured: Through study completion, an average of 5 years
Secondary outcomes (4)
Apparent-Diffusion Coefficient (ADC) of Xe gas within the alveolar airspace.
Measurement of the Xe apparent-diffusion coefficient (ADC), in units of cm^2/s, with a larger value indicating more airspace dilation.
Measured: Through study completion, an average of 5 years
Xenon RBC:Membrane ratio
The ratio of Xe signal intensity (in arbitrary units) within the red-blood cell (RBC) compartment and membrane (interstitial tissue) compartments of pulmonary diffusion measured during dissolved-phase Xe MRI.
Measured: Through study completion, an average of 5 years
Xe gas time constant
The rate at which Xe gas signal intensity changes during dynamic images, in arbitrary units/second.
Measured: Through study completion, an average of 5 years
Length in time of Xe MRI acquisition
Measurement of time in seconds for the duration of the Xe MRI acquisition.
Measured: Through study completion, an average of 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 Sep 2026
- Study start1 Jan 2024
- Primary completionJan 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSCTStudies 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823010
- Sponsor's protocol ID
- 2023-0524
- Status last verified
- Jan 2026
- First submitted
- 26 Sep 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Development of Xe MRI in Children and Adults
- ClinicalTrials.gov ID
- NCT07823010
- Acronym / sponsor ID
- 2023-0524
- Conditions
- HSCT, Lung Transplant Recipient
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 16 Sep 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.
The goal of this study is to develop and optimize new proton (1H; conventional MRI) and Xe gas MRI techniques to assess regional cardiopulmonary structure and function in the clinical setting. Specifically, three forms of Xe MRI techniques will be our focus: (1) imaging of the Xe ventilation distribution (which is the current FDA-approved indication for Xe MRI); (2) imaging the alveolar microstructure via the Xe apparent diffusion coefficient (ADC); and (3) detecting via spectroscopy and imaging Xe gas dissolved in the pulmonary blood and tissues upon inhalation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperpolarized 129 Xenon | Experimental | Drug: Hyperpolarized 129 XenonThis research study will happen immediately following the clinical MRI exam with additional research Xe doses administered after the clinical Xe MRI procedure. Xe gas will be administered to the participant in the same manner as the clinical Xe MRI scan. Research scans without Xe gas may be acquired as well. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participant is having a clinically-ordered hyperpolarized Xe gas MRI scan
Key exclusion criteria (2 listed)
- Pregnancy or positive pregnancy test
- Standard MRI exclusions
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 XenonThe total dosing volume will be consistent with CCHMC Department of Radiology clinical standards or up to 1/6th of a participant's total lung capacity (calculated or predicted from ATS guidelines or from participant's plethysmography data if available within 6 months of MRI scan) for participants under 18 years old and 1000 milliliters for adults. No more than a total of five Xe gas doses, combined clinical and research doses, will be administered during the scanning session. | Drug | Hyperpolarized 129 Xenon |
Primary outcome
Xenon gas Defect Distribution Index (DDI)
Time frame: Through study completion, an average of 5 years
The signal intensity of Xe gas in a voxel (in arbitrary units) as compared to neighboring voxels, with a higher DDI indicating more clustered and focal Xe defects.
4 secondary outcomes
Apparent-Diffusion Coefficient (ADC) of Xe gas within the alveolar airspace.
Time frame: Through study completion, an average of 5 years
Xenon RBC:Membrane ratio
Time frame: Through study completion, an average of 5 years
Xe gas time constant
Time frame: Through study completion, an average of 5 years
Length in time of Xe MRI acquisition
Time frame: Through study completion, an average of 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 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hyperpolarized 129 Xenon in people with HSCT and Lung Transplant Recipient, run by Children's Hospital Medical Center, Cincinnati 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 1 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 16 Sep 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Xenon gas Defect Distribution Index (DDI) (time frame: Through study completion, an average of 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 16 Sep 2026.