Hyperpolarized 129Xe MRI for Imaging Pulmonary Function in Lung Disease

Overseen By Cody Blanton

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bastiaan Driehuys

Disqualifiers: Cardiac arrhythmia, Pregnancy, Respiratory illness, 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: 1

445 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using MRI with a special gas, 129Xe, to better visualize lung function. Researchers aim to understand lung diseases like fibrosis, emphysema, and pulmonary hypertension by observing how the gas moves through the lungs. Potential participants include individuals diagnosed with lung issues who have not experienced a flare-up in the last 30 days, as well as healthy individuals with no smoking history in the past five years. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in understanding lung diseases.

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 might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this MRI technique is safe for imaging pulmonary function?

Research has shown that hyperpolarized 129Xe MRI, which uses a special type of xenon gas for imaging, holds promise for assessing lung function. Studies have demonstrated that this technique provides clear images of lung function. Importantly, previous studies of hyperpolarized 129Xe MRI reported no negative side effects, although these studies did not specifically focus on testing safety and comfort.

Xenon gas is already considered safe in other medical uses, suggesting that this MRI method should be well-tolerated. In the current trial phase, researchers are still gathering detailed safety information. This phase usually indicates some evidence of safety exists, but more data is needed to confirm it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Hyperpolarized 129Xe MRI is unique because it uses a special form of xenon gas to create highly detailed images of lung function, unlike traditional imaging methods like CT scans or standard MRIs that primarily show structure. Researchers are excited because this technique can reveal how well different parts of the lungs are working, providing insights into lung diseases that current methods can't easily offer. This could lead to better diagnosis and monitoring of lung diseases, potentially improving personalized treatment plans for patients.

What evidence suggests that Hyperpolarized 129Xe MRI is effective for imaging pulmonary function in lung disease?

Research has shown that hyperpolarized xenon-129 MRI (129Xe MRI) offers a promising way to evaluate lung function. This technique uses a special gas to produce detailed images of air movement and gas exchange in the lungs. Studies have found that 129Xe MRI accurately detects and assesses lung diseases such as fibrosis and emphysema. This noninvasive method, which does not involve surgery or entering the body, provides a clear picture of lung health. Early results suggest it can be as effective as other methods, like 133Xe scintigraphy, while offering more detailed information on lung function. ^{2 4 6 7 8}

Who Is on the Research Team?

Joseph Mammarappallil, M.D.

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults with stable lung function who haven't had a worsening of their condition in the last month. Smokers can join if they've smoked 5 or fewer pack-years. There's also a group for healthy people without lung issues and who haven't smoked in 5 years.

Inclusion Criteria

I have not smoked in the last 5 years.

Smoking history, if any, is less than or equal to 5 pack-years

I have been diagnosed with lung disease by a doctor.

Exclusion Criteria

Subject is pregnant or lactating

I cannot hold my breath for 15 seconds.

Subject does not fit into 129Xe vest coil used for MRI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo HP 129Xe MRI to assess pulmonary function, including ventilation distribution, alveolar microstructure, and gas exchange.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging, with a focus on recording any adverse events.

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 129Xe MRI

Trial Overview The study is testing MRI scans using a special gas called Hyperpolarized Xenon-129 to see how well different parts of the lungs are working, looking at air distribution, tiny air sacs (alveoli), and how gas transfers into blood and tissues.

Who Is Running the Clinical Trial?

Bastiaan Driehuys

Lead Sponsor

Trials

15

Recruited

1,100+

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 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 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]

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 (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]

Citations

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

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

2. pubs.rsna.org pubs.rsna.org/doi/10.1148/ryct.240562

Hyperpolarized 129Xe MRI and Spectroscopy Hyperpolarized xenon 129 (129Xe) MRI uses inhaled 129Xe gas to visualize pulmonary function and microstructure.

3. 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03418090

Study Details | NCT03418090 | Hyperpolarized Xenon MRI ... This study compares the equivalence of hyperpolarized 129Xe MRI to 133Xe scintigraphy for the evaluation of pulmonary function in patients being evaluated for ...

5. pulmonologyadvisor.com pulmonologyadvisor.com/features/129xe-mri-offers-detailed-view-of-pulmonary-function-and-huge-clinical-potential/

129Xe MRI Offers Detailed View of Pulmonary Function ... Hyperpolarized 129xenon gas MRI (129Xe MRI), a noninvasive technology offering a highly detailed view of lung function, holds great clinical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3244666/

Safety and Tolerability of Hyperpolarized 129Xe MR ... Although these studies reported no adverse events, they were not specifically designed to assess the safety and tolerability of hyperpolarized 129Xe. Xenon, ...

7. 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 ...

8. 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 ...