Xenon MRI for Pulmonary Fibrosis

Overseen By Claudia Salazar

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Duke University

Must not be taking: Nintedanib, Pirfenidone

Disqualifiers: Pregnancy, Cardiac arrhythmia, 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 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special type of MRI using hyperpolarized xenon gas can track lung changes in individuals with progressive pulmonary fibrosis, a condition where lung tissue scars over time. Researchers aim to determine if this imaging technique can reveal lung function and detect changes after starting anti-fibrotic treatments. The trial targets individuals diagnosed with interstitial lung diseases, such as chronic hypersensitivity pneumonitis or autoimmune-related lung issues, whose conditions have worsened in the past two years. Participants will undergo imaging before and after treatment to help doctors better understand disease progression. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, certain immunosuppressive medications are allowed if your doctor agrees.

What prior data suggests that this MRI protocol is safe for patients with pulmonary fibrosis?

Research has shown that hyperpolarized 129 Xenon gas is a safe tool for lung imaging, helping doctors assess lung function. Previous studies with people reported no serious side effects from inhaling this gas.

This gas is not a new treatment; it simply provides a clearer view of lung function. Patients generally tolerate it well. Although the study under consideration is in an early phase, indicating much remains to be learned, past research has not revealed any major safety concerns with using hyperpolarized 129 Xenon gas for imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using hyperpolarized 129 Xenon gas in MRI scans for pulmonary fibrosis because it offers a new way to visualize lung function. Unlike standard treatments that focus on slowing disease progression with medications like antifibrotics, this approach provides detailed images of how the lungs are working in real-time. This technique has the potential to detect changes in lung function earlier and more accurately, helping doctors make better treatment decisions for patients with progressive pulmonary fibrosis.

What evidence suggests that this MRI technique is effective for visualizing lung function in pulmonary fibrosis?

Research has shown that using hyperpolarized 129 Xenon gas in MRI scans can detect changes in lung function over time, particularly in diseases like pulmonary fibrosis. This trial will employ hyperpolarized 129 Xenon gas MRI to visualize impaired lung function in patients with Progressive Pulmonary Fibrosis who are receiving approved treatments. Studies have found that this imaging method can identify areas where the lungs aren't functioning well, which is crucial for tracking disease progression. In earlier studies, patients with lung fibrosis demonstrated clear differences in lung function when this technology was used. This method allows doctors to see and measure lung problems without surgery or other invasive tests. By identifying these changes early, treatments can be adjusted to better manage the condition. ^{1 3 4 6 7}

Who Is on the Research Team?

Robert M Tighe, MD

Principal Investigator

Duke University Health Systems

Are You a Good Fit for This Trial?

This trial is for adults over 18 with physician-diagnosed progressive fibrosis interstitial lung disease (ILD) who have shown signs of the disease getting worse in the last 24 months. They must be able to consent and follow the study plan. People can't join if they've had certain respiratory illnesses recently, previous treatments with specific anti-fibrotic drugs, or are pregnant.

Inclusion Criteria

My doctor approves of my immunosuppressive medication use.

My lung condition has worsened in the last 2 years.

Willing and able to give informed consent and adhere to visit/protocol schedules

Exclusion Criteria

Subject deemed unlikely to be able to comply with instructions during imaging

I have previously been treated with nintedanib or pirfenidone.

I had a cardiac arrest in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline MRI and Initial Assessment

Subjects undergo a comprehensive MRI protocol including administration of multiple doses of hyperpolarized 129Xe prior to initiation of anti-fibrotic therapies.

1 day

1 visit (in-person)

Treatment and Monitoring

Participants receive anti-fibrotic therapy and undergo repeat MRI studies at 3, 6, and 12 months following the initiation of therapy. Additional studies include pulmonary function tests, biomarker analysis, and HRCT at specified intervals.

12 months

3 visits (in-person) at 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment through periodic reviews of the medical record.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 129 Xenon Gas

Trial Overview

The study at Duke University tests how well hyperpolarized 129 Xenon Gas MRI works in monitoring ILD progression before and after starting anti-fibrotic therapy. Participants will undergo MRIs prior to treatment and then again at 3, 6, and 12 months into their therapy.

How Is the Trial Designed?

Group I: Progressive Pulmonary Fibrosis Experimental Treatment 1 Intervention

Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Progressive Pulmonary Fibrosis patients receiving approved treatments.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

Hyperpolarized noble gas MRI using helium-3 or xenon-129 enhances MRI signal, making it a promising method for imaging lung function and ventilation.

While there are safety considerations and challenges in clinical application, this technology holds potential for better understanding lung microstructure and function in various pulmonary diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. Liu, Z., Araki, T., Okajima, Y., et al.[2017]

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 (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 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]

A new continuous-flow system for producing hyperpolarized xenon (129Xe) has been developed, achieving production rates of 0.3 liters per hour with 64% polarization, significantly improving the availability of this imaging agent for lung MRI studies.

This technology allows for the production of multiliter quantities of hyperpolarized xenon several times daily, enabling more extensive human lung imaging studies that were previously limited by the availability of hyperpolarized gas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large production system for hyperpolarized 129Xe for human lung imaging studies. Hersman, FW., Ruset, IC., Ketel, S., et al.[2022]

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.

mdpi.com

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

Hyperpolarized Xenon-129 MRI: Narrative Review of ...

Publications using 129XeMRI to assess clinical observations or outcomes in pulmonary diseases such as chronic obstructive pulmonary disease (COPD), asthma, ...

4.

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 ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37371626/

Hyperpolarized Xenon-129: A New Tool to Assess Pulmonary ...

Lung MRI imaging using inhaled hyperpolarized xenon-129 gas ( 129 Xe) as a contrast agent is a new technology for measuring regional lung physiology.

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 ...