Hyperpolarized Xenon MRI for Infant Lung Imaging

Recruiting at 1 trial location

Overseen By Carrie Stevens

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: Sedatives, Vasodilators, Inotropes, others

Disqualifiers: ECMO, Respiratory infection, Heart disease, 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: 1

Duration: 1 day

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to safely image infant lungs using a special MRI technique with hyperpolarized xenon (129Xe). The goal is to enhance lung imaging without exposing infants to the harmful radiation associated with traditional X-rays and CT scans. The trial includes infants in the NICU who require respiratory support, such as a nasal cannula or devices like CPAP. This research could improve the detection and understanding of lung issues in newborns. Infants needing oxygen or other breathing support in the NICU might be suitable candidates. As a Phase 4 trial, this research uses an FDA-approved technique to assess its benefits for more patients, providing a safe imaging option for infants.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications. However, it does exclude those who have had general anesthesia within 24 hours or sedation like morphine, Versed, or fentanyl within the last 4 hours.

What is the safety track record for hyperpolarized xenon MRI in infants?

Research shows that 129Xe, a special gas used in MRI scans, is safe and well-tolerated for lung imaging. Studies have found that breathing in 129Xe during these scans is safe. It enables doctors to assess lung function without harmful radiation.

The FDA has approved its use for evaluating lung function in adults and children aged 6 and older, indicating its high safety profile. Studies have reported no major side effects, confirming its general tolerability for lung imaging.

This method provides a promising way to study lung function safely, particularly important for infants, as it avoids radiation exposure. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using hyperpolarized xenon (129Xe) MRI for infant lung imaging because it offers a non-invasive and detailed view of the lungs, which is particularly important for sensitive populations like infants. Unlike traditional imaging techniques that might involve radiation or less detailed imagery, hyperpolarized xenon MRI provides clearer images of lung function and structure without harmful exposure. This technique can help detect lung issues early on and monitor treatment effects with high precision, offering a safer and more informative alternative to current imaging methods.

What evidence suggests that hyperpolarized xenon MRI is effective for infant lung imaging?

Research has shown that hyperpolarized xenon-129 (129Xe) effectively enhances lung imaging by providing a clear picture of lung function. Studies confirm that inhaling 129Xe is safe and well-tolerated, allowing doctors to obtain detailed images of air movement in the lungs without radiation. This method is particularly useful for identifying and understanding lung problems in infants, such as breathing difficulties. In this trial, researchers will study infants under various conditions, including using oxygen with a nasal cannula or requiring respiratory support with high-flow nasal cannula (HFNC), continuous positive airway pressure (CPAP), or RAM cannula. Using 129Xe in MRI improves image quality, leading to more accurate diagnoses of lung conditions. This technique has already been approved for assessing lung function in adults, demonstrating its effectiveness. ^{1 3 4 6 7}

Who Is on the Research Team?

Jason Woods, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for infants aged 0-6 months in the NICU who need a bit more breathing support but are stable enough to undergo MRI, without severe heart disease, genetic issues affecting lung development, or recent surgery. They should not have had anesthesia recently and must fit into the NICU MRI scanner.

Inclusion Criteria

My oxygen levels stay above 88% with nasal oxygen support.

I am under 6 months old.

I am a stable NICU patient who can safely undergo an MRI.

Exclusion Criteria

I need medication to widen my blood vessels.

I have an irregular heartbeat that is not under control.

I have genetic issues that could affect my lung development.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants undergo hyperpolarized 129Xe MR lung imaging with a brief hypoxic challenge in a controlled setting

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 129Xe

Trial Overview The study tests hyperpolarized Xenon (129Xe) as an MR imaging agent to visualize infant lung function safely without ionizing radiation. It aims to improve diagnosis and treatment assessment for various lung conditions in newborns.

How Is the Trial Designed?

Group I: Oxygen with nasal cannula Experimental Treatment 1 Intervention

6 infants on oxygen with nasal cannula

Group II: HFNC, CPAP, or RAM cannula Experimental Treatment 1 Intervention

6 infants currently requiring respiratory support with high flow nasal cannula (HFNC), continuous positive airway pressure (CPAP) or RAM cannula

129Xe is already approved in United States for the following indications:

Approved in United States as Xenoview for:

• Evaluation of lung ventilation in adults and pediatric patients aged 12 years and older

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

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]

In a study involving 37 children with asthma and healthy controls, hyperpolarized 129Xe MRI revealed that children with asthma had significantly higher ventilation defect percentages (VDP) and more defects per image slice compared to healthy peers, indicating that this imaging technique can effectively identify lung ventilation issues in pediatric asthma.

The study found that higher VDP and defect counts were associated with increased health care utilization and oral corticosteroid use, suggesting that 129Xe MRI could serve as a valuable biomarker for assessing asthma severity and predicting exacerbation risk in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

129Xe MRI as a measure of clinical disease severity for pediatric asthma. Lin, NY., Roach, DJ., Willmering, MM., 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]

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]

Inhalation of hyperpolarized xenon-129 (129Xe) was found to be safe and well tolerated among 44 subjects, including healthy individuals and patients with chronic obstructive pulmonary disease (COPD), with no serious adverse events reported.

While 91% of participants experienced mild and transient symptoms such as dizziness and euphoria, these symptoms resolved quickly without the need for clinical intervention, indicating that the procedure is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic obstructive pulmonary disease: safety and tolerability of hyperpolarized 129Xe MR imaging in healthy volunteers and patients. Driehuys, B., Martinez-Jimenez, S., Cleveland, ZI., et al.[2022]

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]

Hyperpolarized 129 Xe MRI has shown promise in assessing lung function in neonates with bronchopulmonary dysplasia (BPD), demonstrating good image quality and sensitivity to detect mild ventilation abnormalities in a small study of 9 patients.

The study found elevated apparent diffusion coefficients (ADCs) in BPD patients compared to healthy individuals, indicating potential lung microstructural changes, and a low red blood cell to tissue membrane signal ratio, suggesting altered gas exchange in these infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial feasibility and challenges of hyperpolarized 129 Xe MRI in neonates with bronchopulmonary dysplasia. Stewart, NJ., Higano, NS., Mukthapuram, S., 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5083137/

Feasibility, tolerability and safety of pediatric hyperpolarized ... Our data indicate that 129Xe is a safe and easily tolerated inhaled contrast agent for pulmonary imaging, paving the way for studies of other pulmonary diseases ...

2. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/214375s001lbl.pdf

XENOVIEW (xenon Xe 129 hyperpolarized), for oral inhalation XENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02740868

Xenon-129 and Inert Fluorinated Gas Lung Magnetic ... Aim of this study is to evaluate image quality and reproducibility of Xenon-129 and Inert fluorinated (19F) gas Magnetic Resonance Imaging (MRI) and to ...

4. mearis.cms.gov mearis.cms.gov/public/publications/ntap/NTP221017PBF9L

MEARIS™ | Publication | ntap | NTP221017PBF9L - CMS For patients with lung disease that may be prescribed an HP Xe 129 MRI the resulting MS-DRGs are determined by the patient's diagnosis codes, not the XENOVIEW ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/mrm.30250

Improving Xenon‐129 lung ventilation image SNR with ... 129 Xe ventilation image SNR was improved with DL reconstruction when compared with conventionally reconstructed images.

6. mayoclinic.org mayoclinic.org/drugs-supplements/xenon-xe-129-hyperpolarized-inhalation-route/description/drg-20543669

Xenon xe 129 hyperpolarized (inhalation route) Xenon Xe 129 is a hyperpolarized contrast agent that is inhaled before an MRI to help diagnose problems in the lungs.

7. pulmonologyadvisor.com pulmonologyadvisor.com/news/xenoview-approved-for-evaluation-of-lung-ventilation-in-younger-patients/

Xenoview Approved for Evaluation of Lung Ventilation in ... The FDA has expanded the approval of Xenoview (xenon Xe 129 hyperpolarized) to include use in pediatric patients aged 6 years and older.