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

Trial Summary

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 data supports the effectiveness of the treatment Hyperpolarized Xenon-129 MRI for Idiopathic Pulmonary Fibrosis?

The research suggests that Hyperpolarized Xenon-129 MRI is promising for monitoring idiopathic pulmonary fibrosis because it can image how gas moves in the lungs without using harmful radiation. This method can help detect lung function issues and track disease progression, potentially improving diagnosis and treatment response assessment. ^{1 2 3 4 5}

Is Hyperpolarized Xenon-129 MRI safe for humans?

Research indicates that Hyperpolarized Xenon-129 MRI has been studied for safety and tolerability, including in children with cystic fibrosis, suggesting it is generally safe for human use. ^{1 3 4 6 7}

How is the treatment Hyperpolarized Xenon-129 MRI unique for idiopathic pulmonary fibrosis?

Hyperpolarized Xenon-129 MRI is unique because it uses inhaled xenon gas to create detailed images of lung function, allowing doctors to see how well gas is transferred from the airspaces to the blood. This provides a new way to assess lung health in idiopathic pulmonary fibrosis, which is different from traditional methods that don't offer such detailed regional information. ^{1 3 8 9 10}

What is the purpose of this trial?

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.

Research Team

John Kim, MD

Principal Investigator

University of Virginia

Eligibility Criteria

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

I have been diagnosed with idiopathic pulmonary fibrosis.

Able to provide informed consent

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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) 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Hyperpolarized Xenon-129: A New Tool to Assess Pulmonary Physiology in Patients with Pulmonary Fibrosis. [2023]

2. United States 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. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Using hyperpolarized 129Xe MRI to quantify regional gas transfer in idiopathic pulmonary fibrosis. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Hyperpolarised xenon-129 diffusion-weighted magnetic resonance imaging for assessing lung microstructure in idiopathic pulmonary fibrosis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

New Developments in Imaging Idiopathic Pulmonary Fibrosis With Hyperpolarized Xenon Magnetic Resonance Imaging. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Feasibility, tolerability and safety of pediatric hyperpolarized 129Xe magnetic resonance imaging in healthy volunteers and children with cystic fibrosis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Standalone portable xenon-129 hyperpolariser for multicentre clinical magnetic resonance imaging of the lungs. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Transverse relaxation rates of pulmonary dissolved-phase Hyperpolarized 129 Xe as a biomarker of lung injury in idiopathic pulmonary fibrosis. [2021]

9. Ireland pubmed.ncbi.nlm.nih.gov

The role of hyperpolarized 129xenon in MR imaging of pulmonary function. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Repeatability of regional pulmonary functional metrics of Hyperpolarized 129 Xe dissolved-phase MRI. [2020]