HP 129Xe MRI for Lung Function Assessment

(HpXeMRCal Trial)

Overseen By Kelly Thornton, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Heart defect, Pregnancy, Uncontrolled asthma, others

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

Compensation: Varies

Number of Visits: 3

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special kind of MRI using hyperpolarized xenon gas to improve images of lung function. The goal is to determine if this method provides clearer pictures than standard MRI scans. The trial seeks adults who can hold their breath for up to 16 seconds and do not have conditions like frequent asthma attacks or recent respiratory infections. Participants will assist researchers in refining this imaging technique, potentially enhancing future lung assessments. As a Phase 1 trial, the research focuses on understanding how this new imaging method works in people, offering participants an opportunity to contribute to groundbreaking advancements in lung imaging.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this MRI technique is safe for lung function assessment?

Research has shown that using hyperpolarized 129Xe (xenon) gas in MRI scans is generally safe. Past studies reported no problems or side effects from this type of xenon, although these studies did not focus specifically on safety. Since this trial is in its early stages, more detailed safety information might still be needed. Xenon is already used in some medical procedures, which helps reassure about its safety. As always, prospective participants should discuss any concerns with the study team or their doctor. ^{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 lung function assessment because it offers a new way to visualize lung function in greater detail than traditional proton MRI. Unlike typical imaging techniques that might not capture the nuances of gas exchange and airflow in the lungs, this method allows for a clearer picture by enhancing the MRI signal from the inhaled gas. This could lead to more precise diagnostics and better understanding of lung conditions, potentially improving treatment plans for respiratory diseases.

What evidence suggests that this MRI technique is effective for assessing lung function?

Research has shown that hyperpolarized 129Xe MRI, which participants in this trial will undergo, is a promising method for assessing lung function. Studies have found that this MRI can detect changes in lung function earlier than traditional tests. It provides clear images of the lungs, aiding in the identification and assessment of lung issues. The technique involves inhaling a special gas called xenon during the scan, offering a unique view of lung performance. This innovative method may assist in the early detection and improved management of lung diseases. ^{2 4 5 6 7}

Who Is on the Research Team?

Jason C Woods, Ph.D.

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for adults who can hold their breath for up to 16 seconds. It's not suitable for those with heart defects, uncontrolled asthma, low oxygen levels without support, or recent respiratory infections. Pregnant individuals and those with MRI-incompatible implants are also excluded.

Inclusion Criteria

I can hold my breath for up to 16 seconds.

Exclusion Criteria

Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula.

I've had symptoms like a cough, chest tightness, or sinus infection in the last week.

Standard MRI exclusions (metal, implants).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging Session

Participants undergo MRI scans with hyperpolarized 129Xe gas to assess lung function

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

30 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 129 Xenon
• MRI

Trial Overview The study tests the effectiveness of using hyperpolarized Xenon (129Xe) gas during an MRI to assess lung function in healthy adults. The aim is to achieve optimal imaging results that could help understand lung health better.

How Is the Trial Designed?

Group I: Hyperpolarized 129 Xenon Experimental Treatment 2 Interventions

Administration of up to 1 liter doses of Hyperpolarized Xenon gas during MRI to optimize acquisition of images for adults vs. proton MR imaging. These scans, utilizing volunteers for calibration, may be utilized through this study to optimize the scan details.

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

In a study involving 148,489 patients over 10 years, gadoteric acid (Dotarem®) was found to be a safe MRI contrast agent, with only 0.3% of patients experiencing adverse events, primarily mild symptoms like nausea and vomiting.

The diagnostic effectiveness was high, with 99.8% of examinations yielding useful results and excellent or good image quality in 97.7% of cases, indicating that gadoteric acid is effective for routine MRI procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. Braun, J., Busse, R., Darmon-Kern, E., 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]

In a study of 36 patients with MR conditional pacemakers, undergoing heart MRI at 1.5 Tesla was found to be safe, with no adverse events reported during or after the procedure.

While some patients experienced increases in pacing capture thresholds (PCT) after the MRI, these changes were not clinically significant, indicating that the MRI did not adversely affect the function of the pacemaker system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe performance of magnetic resonance of the heart in patients with magnetic resonance conditional pacemaker systems: the safety issue of the ESTIMATE study. Wollmann, CG., Thudt, K., Kaiser, B., et al.[2021]

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]

Magnetic resonance imaging (MRI) is a safe imaging technique that does not use ionizing radiation, but it requires special safety precautions due to the strong magnetic fields involved.

The American College of Radiology has updated its guidelines on MRI safety, reflecting the evolution of safety recommendations and procedures to ensure patient and staff safety during MR imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulating MR Safety Standards. MacIntyre, S.[2021]

In a study of 1334 cardiovascular magnetic resonance (CMR) procedures for patients with congenital heart disease, the overall incidence of adverse events (AEs) was low at 1.6%, with most being minor in severity.

The use of general anesthesia and the status of being an inpatient were identified as independent risk factors for experiencing AEs, particularly in the most critically ill patients, highlighting the need for careful monitoring in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. Dorfman, AL., Odegard, KC., Powell, AJ., et al.[2013]

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]

In a study involving 81 patients, MRI-conditional permanent pacemakers (PPMs) were found to be safe and effective after undergoing multiple MRI scans, with no serious adverse device effects reported.

While there were statistically significant changes in certain PPM function parameters after the MRIs, these changes were not clinically relevant, indicating that the PPMs maintained their performance and safety throughout the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cumulative effects and clinical safety of repeat magnetic resonance imaging on an MRI-conditional pacemaker system at 1.5 tesla. Nguyen, TD., Sandberg, SA., Durrani, AK., et al.[2022]

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 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]

Citations

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

Hyperpolarized Xenon-129: A New Tool to Assess Pulmonary ... Conclusion: The hyperpolarized 129Xe MRI was highly sensitive to regional functional changes in subjects with UIP and may represent a new tool ...

2. 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 ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3558952/

Hyperpolarized 129Xe MRI of the Human Lung - PMC MR imaging using hyperpolarized gases provides unique strategies for evaluating pulmonary structure and function.

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

Hyperpolarized 129 Xe MRI and Spectroscopy Functional deficits in ventilation measured with 129Xe MRI can help detect disease changes earlier than conventional pulmonary function test ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT02272049

Study Details | Use of Hyperpolarized Xenon Gas for Lung ... The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas MRI for regional assessment of lung function in a normal ...