129Xe MRI for Interstitial Lung Disease

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best way to use a special type of MRI scan with xenon gas (Hyperpolarized 129Xe) to monitor interstitial lung diseases (ILDs). It includes both healthy volunteers and individuals with ILDs to study changes in lung gas exchange. Candidates for this study may include those diagnosed with ILD by a lung specialist and individuals without lung problems who have smoked minimally in the last five years. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in ILD monitoring.

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 prior data suggests that this protocol is safe for detecting disease activity in interstitial lung diseases?

Research has shown that hyperpolarized 129Xe, a special gas for MRI scans, is generally safe for people. Studies have found it helps create clear lung images without harming patients. Animal studies revealed no major safety issues. In humans, it has been used successfully for lung conditions like COPD and asthma, with no major side effects reported, suggesting it is well-tolerated. Since this trial is in Phase 2, the treatment has already passed initial safety checks in earlier studies, indicating that experts consider it safe enough for testing in more people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperpolarized 129Xe MRI because it offers a novel way to visualize and understand interstitial lung disease (ILD). Unlike traditional imaging methods, this technique uses hyperpolarized xenon gas to provide detailed images of how gas moves through the lungs, offering insights into lung function and structure that other methods can't capture. This approach could revolutionize the way we diagnose and monitor ILD, potentially leading to earlier detection and more personalized treatment strategies.

What evidence suggests that this protocol is effective for detecting disease activity in interstitial lung diseases?

Research has shown that hyperpolarized 129Xe MRI can track changes in lung diseases like interstitial lung disease (ILD). In earlier studies, this imaging method was strongly linked to lung function and the amount of lung damage seen in CT scans. It can also detect early signs and changes in the lungs, aiding in monitoring disease progression. This trial will compare hyperpolarized 129Xe MRI use in patients with ILD to healthy volunteers. This technology uses a special type of xenon gas to provide clear images of the lungs' condition. These studies suggest that hyperpolarized 129Xe MRI effectively monitors lung diseases non-invasively, helping assess disease progression. ^{1 3 5 6 7}

Who Is on the Research Team?

Joseph Mammarappallil, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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 (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]

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]

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]

Citations

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

Hyperpolarized Xenon-129: A New Tool to Assess Pulmonary ... The quantification of dissolved 129Xe can provide data on gas-exchange derangements in lung disease. In animal studies, lung fibrosis results in ...

2. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.211433

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

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05914506

Hyperpolarized 129-Xenon MRI in Fibrosing Interstitial ... This project aims to investigate the potential of non-invasive imaging to identify and monitor the earliest signs and physiological effects of pulmonary ...

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

Hyperpolarized Xenon-129 MRI: Narrative Review of ... This indicates that three-dimensional single-breath chemical shift imaging 129XeMRI can effectively characterize lung diseases, monitor treatment responses, and ...

5. publications.ersnet.org publications.ersnet.org/content/erj/64/suppl68/oa5465

129Xe magnetic resonance imaging for monitoring lung ... The aim was to investigate the potential of hyperpolarized 129 Xe MR imaging markers for noninvasive assessment of disease progression in patients on ...

6. 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 ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1090780723000228

Hyperpolarized 129Xe MRI at low field: Current status and ... Hyperpolarized 129Xe MRI permits high-sensitivity in-vivo imaging of human lungs. · Improved SNR and longer T2* at low field suggests optimum field strength ...