Idiopathic Pulmonary FibrosisEarly Phase 1XeMRIIPFNCT06853145
Hyperpolarized Xenon-129 MRI in Idiopathic Pulmonary Fibrosis
A Early Phase 1 study testing Hyperpolarized Xe129 in people with Idiopathic Pulmonary Fibrosis, run by University of Virginia at 1 site in United States.
Trial summary
Idiopathic pulmonary fibrosis has a poor prognosis with limited treatment options. The Investigator hypothesize hyperpolarized Xe129-MRI can be performed in patients with IPF and repeated over time which will detect deficiencies related to perfusion in the lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Hyperpolarized Xe129
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to Dec 2027
- Phase
- Early 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent 18 years of age or greater Clinical diagnosis of IPF
Who cannot join
- Continuous oxygen use at home
- Oxygen saturation less than 92% on the day of MRI procedure
- Pregnancy or lactation
- Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
- History of congenital cardiac disease, chronic renal failure, or cirrhosis. • Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches.
- Inability to understand simple instructions or to hold still for approximately 10-15 seconds.
- History of respiratory infection within 2 weeks prior to the MR scan
- History of MI, stroke and/or poorly controlled hypertension.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carol Bampoe, BS contact
United States1 site, 1 recruiting
- Recruiting
Snyder Building 480 Ray C. Hunt Drive
Charlottesville, Virginia, 22908
Roselove Asare, MA, 434-243-6074, rnn3b@uvahealth.org
Carol Bampoe, BS, 4342439634, cb3ff@uvahealth.org
About this study
Idiopathic pulmonary fibrosis has a poor prognosis with limited treatment options. The Investigator hypothesize hyperpolarized Xe129-MRI can be performed in patients with IPF and repeated over time which will detect deficiencies related to perfusion in the lung.
Read the detailed description
Idiopathic pulmonary fibrosis has a poor prognosis with limited treatment options. Idiopathic pulmonary fibrosis (IPF) is a subtype of interstitial lung disease (ILD) that can lead to chronic hypoxic and ventilatory respiratory failure and early death.1 While current treatments slow disease progression, they do not improve symptoms or quality of life and are often poorly tolerated due to significant side effect profiles. Therefore, there remains an unmet need for more tolerable therapies with an acceptable side effect profile that slows progression and improves patient-centered outcomes.
Functional imaging is a promising tool for assessing treatment response in IPF. Longitudinal decline in forced vital capacity (FVC) and time-to-event outcomes like hospitalization and death have been traditional clinical trial endpoints in IPF. However, these endpoints are time and resource-consuming. Thus, there has been significant interest in using other trial endpoints, the most promising of which is lung imaging. The study group employed hyperpolarized xenon-129 magnetic resonance imaging (Xe129-MRI) to quantify and localize deficits in pulmonary ventilation and perfusion in chronic obstructive diseases. It has recently extended this to pulmonary fibrosis. However, to implement Xe129-MRI as an endpoint in a mechanistic clinical trial, the investigator proposes to demonstrate the feasibility of employing this procedure over time in patients with IPF. The investigator hypothesizes that hyperpolarized Xe129-MRI can be performed in patients with IPF and repeated over time, which will detect deficiencies related to perfusion in the lung.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Hyperpolarized Xe129
- Keywords
- Hyperpolarized Xenon-129 gas with MRI
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Xe129Drug
Also called 129 HXe MRI
Hyperpolarized Xe129-MRI: Patients will undergo hyperpolarized Xe129-MRI at the University of Virginia Radiology Imaging Core (Charlottesville, VA, USA). The entire procedure visit takes approximately 3 hours based on our team's experience.
| Study group | Role | What they receive |
|---|---|---|
| IPF subjects | Other | IPF subjects will undergo Xe-129 MRI Receives: Drug: Hyperpolarized Xe129 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the ventilation effect of HXe129 MRI for IPF subjects
We will initially use descriptive statistics to describe the hyperpolarized Xe129 MRI indices and visualize their distribution using histograms. Paired t-test will be used to examine differences between baseline and follow-up hyperpolarized Xe129 MRI indices. Given that SA2 is to prove feasibility of accomplishing the MRI procedure, we have purposely opted to not adjust for the multiple MRI measurements that will be obtained.
Measured: Up to 24 hours post MR Imaging
Secondary outcomes (1)
Measuring the diffusion capacity of HXe 129 for IPF subjects
We will use linear mixed-effects model with random intercept and slope to determine the change in MRI indices over time between baseline and follow-up scans.
Measured: Up to 24 hours post MRI analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 May 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- IPF subjects will be scan via MRI using Hyperpolarized Xenon-129 gas
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Kim, MD, MS, University of Virginia
- Investigators
- John Kim, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853145
- Sponsor's protocol ID
- HSR240022
- Acronym
- XeMRIIPF
- Status last verified
- Apr 2025
- First submitted
- 1 Nov 2024
- Last updated
- 9 Jul 2025
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized Xenon-129 MRI in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT06853145
- Acronym / sponsor ID
- XeMRIIPF / HSR240022
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Hyperpolarized Xenon-129 gas with MRI
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Feb 2025 (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.
Idiopathic pulmonary fibrosis has a poor prognosis with limited treatment options. The Investigator hypothesize hyperpolarized Xe129-MRI can be performed in patients with IPF and repeated over time which will detect deficiencies related to perfusion in the lung.
Detailed description
Idiopathic pulmonary fibrosis has a poor prognosis with limited treatment options. Idiopathic pulmonary fibrosis (IPF) is a subtype of interstitial lung disease (ILD) that can lead to chronic hypoxic and ventilatory respiratory failure and early death.1 While current treatments slow disease progression, they do not improve symptoms or quality of life and are often poorly tolerated due to significant side effect profiles. Therefore, there remains an unmet need for more tolerable therapies with an acceptable side effect profile that slows progression and improves patient-centered outcomes.
Functional imaging is a promising tool for assessing treatment response in IPF. Longitudinal decline in forced vital capacity (FVC) and time-to-event outcomes like hospitalization and death have been traditional clinical trial endpoints in IPF. However, these endpoints are time and resource-consuming. Thus, there has been significant interest in using other trial endpoints, the most promising of which is lung imaging. The study group employed hyperpolarized xenon-129 magnetic resonance imaging (Xe129-MRI) to quantify and localize deficits in pulmonary ventilation and perfusion in chronic obstructive diseases. It has recently extended this to pulmonary fibrosis. However, to implement Xe129-MRI as an endpoint in a mechanistic clinical trial, the investigator proposes to demonstrate the feasibility of employing this procedure over time in patients with IPF. The investigator hypothesizes that hyperpolarized Xe129-MRI can be performed in patients with IPF and repeated over time, which will detect deficiencies related to perfusion in the lung.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- IPF subjects will be scan via MRI using Hyperpolarized Xenon-129 gas
| Arm | Type | Receives |
|---|---|---|
| IPF subjects | Other | Drug: Hyperpolarized Xe129IPF subjects will undergo Xe-129 MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Able to provide informed consent 18 years of age or greater Clinical diagnosis of IPF
Key exclusion criteria (8 listed)
- Continuous oxygen use at home
- Oxygen saturation less than 92% on the day of MRI procedure
- Pregnancy or lactation
- Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
- History of congenital cardiac disease, chronic renal failure, or cirrhosis. • Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches.
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: 129 HXe MRIHyperpolarized Xe129-MRI: Patients will undergo hyperpolarized Xe129-MRI at the University of Virginia Radiology Imaging Core (Charlottesville, VA, USA). The entire procedure visit takes approximately 3 hours based on our team's experience. | Drug | IPF subjects |
Primary outcome
Measuring the ventilation effect of HXe129 MRI for IPF subjects
Time frame: Up to 24 hours post MR Imaging
We will initially use descriptive statistics to describe the hyperpolarized Xe129 MRI indices and visualize their distribution using histograms. Paired t-test will be used to examine differences between baseline and follow-up hyperpolarized Xe129 MRI indices. Given that SA2 is to prove feasibility of accomplishing the MRI procedure, we have purposely opted to not adjust for the multiple MRI measurements that will be obtained.
1 secondary outcome
Measuring the diffusion capacity of HXe 129 for IPF subjects
Time frame: Up to 24 hours post MRI analysis
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 9 Jul 2025.
- 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.
Carol Bampoe, BS contact
John Kim, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hyperpolarized Xe129 in people with Idiopathic Pulmonary Fibrosis, run by University of Virginia 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 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 9 Jul 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Roselove Asare, MA (4342436074, rnn3b@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the ventilation effect of HXe129 MRI for IPF subjects (time frame: Up to 24 hours post MR Imaging). 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 9 Jul 2025.