129Xe MRI for Interstitial Lung Disease

Recruiting at 3 trial locations

Overseen By Bastiaan Driehuys, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bastiaan Driehuys

Disqualifiers: Pregnancy, Cardiac arrhythmia, Cardiac arrest, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

147 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this multi-centered, NIH-sponsored study is to to develop an optimal protocol for using noninvasive 129Xe gas exchange MRI to detect changing disease activity in interstitial lung diseases (ILDs).

Do I need to stop my current medications for the trial?

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 129Xe for Interstitial Lung Disease?

Research shows that Hyperpolarized 129Xe MRI is a promising tool for assessing lung function in conditions like pulmonary fibrosis and idiopathic pulmonary fibrosis. It helps visualize how well gas is transferred in the lungs, which is crucial for understanding and managing these diseases. ^{1 2 3 4 5}

How does 129Xe MRI differ from other treatments for interstitial lung disease?

129Xe MRI is unique because it uses inhaled hyperpolarized xenon-129 gas as a contrast agent to provide detailed images of lung function, specifically assessing both ventilation and gas transfer. This imaging technique offers a novel way to evaluate lung physiology, which is different from traditional methods that may not capture these aspects as effectively. ^{1 3 5 6 7}

Research Team

Joseph Mammarappallil, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for adults over 18 with Interstitial Lung Disease diagnosed by a specialist. Participants must be able to consent and follow the study plan. It's not for those with low oxygen levels, recent respiratory infections, MRI contraindications, pregnant or breastfeeding women, or individuals unable to hold their breath for 15 seconds.

Inclusion Criteria

Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)

I have been diagnosed with Interstitial Lung Disease by a lung specialist.

Exclusion Criteria

Your oxygen level while resting is less than 90% on room air.

I have a history of irregular heartbeats from the lower chambers of my heart.

Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Protocol Development

Participants undergo 129Xe gas exchange MRI to develop an optimal protocol for detecting disease activity in ILDs

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after imaging protocol development

4 weeks

Treatment Details

Interventions

• Hyperpolarized 129Xe

Trial Overview The study aims to perfect a noninvasive lung imaging technique using Hyperpolarized 129Xe gas exchange MRI. This method could help visualize how ILD responds to treatments across multiple centers involved in this NIH-sponsored research.

Participant Groups

Group I: Healthy Volunteers Active Control 1 Intervention

Group II: Patients with Interstitial Lung Disease Active Control 1 Intervention

Who Is Running the Clinical Trial?

Bastiaan Driehuys

Lead Sponsor

Trials

15

Recruited

1,100+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

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 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]

Hyperpolarized 129 Xenon-MRI (HP 129 Xe MRI) is a new imaging technique that can assess both how well air moves in and out of the lungs (ventilation) and how effectively gases are transferred in the lungs.

While most studies have focused on non-cancer lung diseases, HP 129 Xe MRI shows great potential for improving the management and understanding of lung cancer by evaluating these key lung functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. Song, EJ., Kelsey, CR., Driehuys, B., et al.[2022]

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 129Xe MRI (HypX-MRI) shows great promise as a new diagnostic tool, enhancing the detectability of lung structures and potentially allowing for better imaging of lipid-rich tissues, which has been challenging with traditional methods.

This technique could help identify issues like ventilation-perfusion mismatch in pulmonary diseases and may also be used for functional MRI studies of the brain, opening new avenues for understanding lung function and brain perfusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of hyperpolarized noble gas MRI. Albert, MS., Balamore, D.[2019]

The recent FDA approval of hyperpolarized 129Xe as an MR contrast agent highlights its growing importance in lung imaging, prompting the need for standardized techniques across research and clinical sites.

The 129Xe MRI Clinical Trials Consortium has established best practices for the entire workflow of 129Xe MRI, including safety monitoring and technical considerations, to ensure effective and safe imaging of lung ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acquiring Hyperpolarized 129Xe Magnetic Resonance Images of Lung Ventilation. Garrison, WJ., Mugler, JP., Mata, JF., et al.[2023]

Hyperpolarized 129Xe MRI is a new imaging technique that allows for detailed lung imaging and can also detect 129Xe in the brain, providing insights into brain parenchyma and blood vessels.

The study outlines specific protocols for using 129Xe MRI in both rodents and humans, highlighting its potential for advanced medical imaging applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain Imaging Using Hyperpolarized 129Xe Magnetic Resonance Imaging. Chahal, S., Prete, BRJ., Wade, A., et al.[2019]

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

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

3. Australia pubmed.ncbi.nlm.nih.gov

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. [2022]

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

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

Development of hyperpolarized noble gas MRI. [2019]

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

Acquiring Hyperpolarized 129Xe Magnetic Resonance Images of Lung Ventilation. [2023]

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

Brain Imaging Using Hyperpolarized 129Xe Magnetic Resonance Imaging. [2019]