Hyperpolarized Xenon-129 MRI for Idiopathic Pulmonary Fibrosis

(XeMRIIPF Trial)

Overseen By Carol Bampoe, BS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Virginia

Disqualifiers: Continuous oxygen use, Pregnancy, Claustrophobia, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 24 hours

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to examine lungs affected by idiopathic pulmonary fibrosis (IPF), a condition that thickens and scars lung tissue over time. Researchers are testing a special MRI scan using hyperpolarized Xenon-129 gas to detect changes in lung function, particularly related to blood flow within the lungs. Individuals with a clinical diagnosis of IPF who do not require continuous oxygen at home and can remain still briefly during the scan may be suitable for this trial. As an Early Phase 1 trial, this research aims to understand how the new MRI scan functions in people, offering participants a chance to contribute to pioneering medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that hyperpolarized Xenon-129 MRI is safe for patients with idiopathic pulmonary fibrosis?

Research shows that hyperpolarized Xenon-129 MRI is a promising method for assessing lung health. Previous studies have found that it can detect changes in lung function that other methods might miss.

Regarding safety, hyperpolarized Xenon-129 is generally well-tolerated and has been used in other studies without major issues. The FDA has approved it for certain uses, suggesting it is considered safe in those contexts. This approval adds confidence in its safety.

However, this current study is in an early phase, representing one of the initial steps in testing. The main goal is to determine if the treatment is safe and effective. While early trials primarily focus on safety, they do not provide complete assurance. Nonetheless, the tool's past use and FDA approval for other purposes are positive indicators. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for idiopathic pulmonary fibrosis (IPF) focus on slowing disease progression using medications like pirfenidone and nintedanib. Unlike these standard options, which primarily target fibrosis and inflammation, hyperpolarized Xenon-129 MRI offers a novel approach by enhancing the imaging of lung function. This method provides detailed insights into lung ventilation and gas exchange, potentially allowing for earlier and more accurate diagnosis and monitoring of IPF. Researchers are excited about this technique because it could lead to more personalized treatment plans and better outcomes for patients by closely tracking how their lungs are functioning over time.

What evidence suggests that hyperpolarized Xenon-129 MRI is effective for idiopathic pulmonary fibrosis?

Research has shown that a special type of MRI using hyperpolarized Xenon-129, which participants in this trial will undergo, can effectively detect lung problems in individuals with idiopathic pulmonary fibrosis (IPF). Studies have demonstrated that this imaging method can identify early changes in lung appearance and function in IPF patients. It helps pinpoint issues with air movement through the lungs, crucial for understanding disease progression. Some findings suggest it can also predict future changes in the disease, such as decreases in lung capacity. Overall, evidence supports hyperpolarized Xenon-129 MRI as a promising tool for detecting and tracking lung damage in IPF. ^{1 6 7 8 9}

Who Is on the Research Team?

John Kim, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with Idiopathic Pulmonary Fibrosis who can consent to the study. It's not suitable for those with claustrophobia, metal implants, severe heart conditions, chronic kidney failure, cirrhosis, or those needing continuous oxygen. Pregnant or lactating individuals and those with recent respiratory infections are also excluded.

Inclusion Criteria

Able to provide informed consent

I have been diagnosed with idiopathic pulmonary fibrosis.

Exclusion Criteria

I can follow simple instructions and remain still for 10-15 seconds.

I don't have conditions or devices that prevent MRI scans.

I have had a heart attack, stroke, or my high blood pressure is not well controlled.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hyperpolarized Xe-129 MRI to assess pulmonary ventilation and perfusion

Up to 24 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in MRI indices over time

Up to 24 hours post MRI analysis

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized Xenon-129

Trial Overview The trial tests whether a type of lung imaging called Hyperpolarized Xenon-129 MRI can help detect changes in lung perfusion over time in patients with Idiopathic Pulmonary Fibrosis.

How Is the Trial Designed?

Group I: IPF subjects Experimental Treatment 1 Intervention

IPF subjects will undergo Xe-129 MRI

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

Hyperpolarized xenon-129 MRI detected significant lung function impairments in patients with usual interstitial pneumonia (UIP), showing a ventilation defect fraction of 30% compared to 21% in healthy controls, indicating its efficacy in identifying lung abnormalities.

The MRI also revealed elevated levels of xenon dissolved in the lung interstitium in UIP patients, which could serve as an early indicator of lung fibrosis, even when traditional pulmonary function tests showed normal or mild impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized Xenon-129: A New Tool to Assess Pulmonary Physiology in Patients with Pulmonary Fibrosis. Qing, K., Altes, TA., Mugler, JP., et al.[2023]

Hyperpolarized 129Xe MRI effectively identifies functional impairment in patients with idiopathic pulmonary fibrosis (IPF), showing a significant increase in barrier uptake compared to healthy individuals, indicating its potential as a diagnostic tool.

The MRI metrics correlated strongly with pulmonary function tests (PFTs) but poorly with CT fibrosis scores, suggesting that 129Xe MRI may provide a more accurate assessment of lung function and disease progression in IPF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using hyperpolarized 129Xe MRI to quantify regional gas transfer in idiopathic pulmonary fibrosis. Wang, JM., Robertson, SH., Wang, Z., et al.[2018]

The study involving 13 healthy volunteers demonstrated that MRI measurements of gas exchange using hyperpolarized 129 Xenon show good repeatability, particularly for the RBC:Barrier ratio, which had a high intraclass correlation coefficient of 0.92.

The RBC:Barrier ratio was strongly correlated with intervisit changes in DLCO, indicating its potential as a reliable imaging biomarker for assessing pulmonary function, independent of lung inflation volume.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeatability of regional pulmonary functional metrics of Hyperpolarized 129 Xe dissolved-phase MRI. Hahn, AD., Kammerman, J., Evans, M., et al.[2020]

A portable xenon-129 (129Xe) hyperpolariser was successfully designed and built, allowing for clinically accessible lung MRI without the need for external utilities, making it easy to transport and set up in hospital settings.

The system was tested by transporting it 200 km to a hospital, where it produced high-quality 129Xe MR images within a day of installation, demonstrating its feasibility for multicentre clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standalone portable xenon-129 hyperpolariser for multicentre clinical magnetic resonance imaging of the lungs. Norquay, G., Collier, GJ., Rodgers, OI., et al.[2023]

Hyperpolarized (HP) Xe magnetic resonance imaging (MRI) offers a promising noninvasive method to assess lung function and gas exchange in patients with idiopathic pulmonary fibrosis (IPF), addressing limitations of traditional imaging techniques.

This review highlights the potential of HP Xe MRI to provide valuable biomarkers for diagnosing, prognosing, and monitoring treatment responses in IPF, suggesting it could play a crucial role in improving patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Developments in Imaging Idiopathic Pulmonary Fibrosis With Hyperpolarized Xenon Magnetic Resonance Imaging. Mammarappallil, JG., Rankine, L., Wild, JM., et al.[2023]

The continuous flow-type hyperpolarizing (CF-HP) system allows for effective lung imaging using hyperpolarized (129)Xe MRI at very low concentrations of xenon, minimizing the anesthetic effects and reducing xenon consumption.

Using a 70% xenon gas mixture resulted in better signal-to-noise ratios for both gas and dissolved-phase images compared to a 3% mixture, although the apparent diffusion coefficient (ADC) was higher with the 3% mixture, indicating a complex relationship between concentration and imaging quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 129 Xe MRI of the mouse lung at a low xenon concentration using a continuous flow-type hyperpolarizing system. Wakayama, T., Kitamoto, M., Ueyama, T., et al.[2015]

Hyperpolarized (HP) noble gas MRI, particularly using 129Xe, has shown promising results in assessing lung ventilation and regional lung physiology, making it a potential game-changer in pulmonary medicine.

Despite being limited to select academic institutions currently, advancements in polarizer technology suggest that HP 129Xe MRI could soon become more widely available for clinical use, enhancing the diagnostic capabilities for lung conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of hyperpolarized 129xenon in MR imaging of pulmonary function. Ebner, L., Kammerman, J., Driehuys, B., et al.[2018]

Hyperpolarized 129Xe gas is safe and well-tolerated as an inhaled contrast agent for MRI in children, with no serious adverse events reported during the study involving 28 participants aged 6 to 16 years.

While some children experienced mild and temporary changes in oxygen saturation and heart rate after inhalation, these effects were consistent with expected physiological responses and resolved quickly, indicating that 129Xe MRI is feasible for assessing lung function in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, tolerability and safety of pediatric hyperpolarized 129Xe magnetic resonance imaging in healthy volunteers and children with cystic fibrosis. Walkup, LL., Thomen, RP., Akinyi, TG., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11854573/

Hyperpolarized Xenon-129 MRI: Narrative Review of Clinical ... Publications using 129XeMRI to assess clinical observations or outcomes in pulmonary diseases such as chronic obstructive pulmonary disease (COPD), asthma, ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06853145?draw=2&rank=1

Hyperpolarized Xenon-129 MRI in Idiopathic Pulmonary ... Longitudinal decline in forced vital capacity (FVC) and time-to-event outcomes like hospitalization and death have been traditional clinical trial endpoints in ...

3. publications.ersnet.org publications.ersnet.org/content/erjor/9/4/00048-2023

Hyperpolarised xenon-129 diffusion-weighted magnetic ... 129 Xe DW-MRI measurements appear to be sensitive to early changes of microstructural disease that are consistent with progression in IPF at 12 months.

4. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.211433

Hyperpolarized 129Xe MR Spectroscopy in the Lung ... In a prospective study, reduced lung function at hyperpolarized 129Xe MRI and extent of fibrotic structure at CT were associated with ...

5. withpower.com withpower.com/trial/early-phase-1-idiopathic-pulmonary-fibrosis-2-2025-dc66a

Hyperpolarized Xenon-129 MRI for Idiopathic Pulmonary ... Hyperpolarized 129Xe MRI effectively identifies functional impairment in patients with idiopathic pulmonary fibrosis (IPF), showing a significant increase in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10294784/

Hyperpolarized Xenon-129: A New Tool to Assess Pulmonary ... Conclusion: The hyperpolarized 129Xe MRI was highly sensitive to regional functional changes in subjects with UIP and may represent a new tool ...

7. mdpi.com mdpi.com/2075-4418/15/4/474

Hyperpolarized Xenon-129 MRI: Narrative Review of ... Hyperpolarized xenon-129 MRI (129XeMRI) has emerged as a powerful tool in the identification, evaluation, and assessment of disease endotyping and in ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/214375Orig1s000lbl.pdf

XENOVIEW (xenon Xe 129 hyperpolarized), for oral inhalation The safety and efficacy of XENOVIEW were evaluated in two prospective, multi-center, randomized, open-label, cross-over clinical trials that compared XENOVIEW ...

9. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.220069

Lung Abnormalities Detected with Hyperpolarized 129 Xe ... Hyperpolarized xenon 129 MRI and total lung diffusion capacity for carbon monoxide demonstrate significantly impaired gas transfer in nonhospitalized ...