100 Participants Needed

HP 129Xe MRI for Lung Function Assessment

(HpXeMRCal Trial)

CS
KT
Overseen ByKelly Thornton, BS
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Children's Hospital Medical Center, Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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 population of adults for the purposes of obtaining optimal images through MRI.

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 data supports the effectiveness of the treatment HP 129Xe MRI for lung function assessment?

Research shows that HP 129Xe MRI is effective in assessing lung function by providing detailed images of how air moves and exchanges in the lungs. This imaging technique has been promising in evaluating lung diseases and is gaining attention for its ability to visualize lung ventilation and gas transfer.12345

Is HP 129Xe MRI safe for humans?

The safety of MRI, including HP 129Xe MRI, is generally well-established as it does not use ionizing radiation. However, strong magnetic fields require specific safety measures, and the American College of Radiology provides guidelines to ensure safe use. No specific safety data for HP 129Xe MRI is mentioned, but general MRI safety standards apply.678910

How is HP 129Xe MRI different from other lung function assessments?

HP 129Xe MRI is unique because it uses hyperpolarized xenon gas to provide detailed images of lung ventilation and gas exchange, offering insights into both the structure and function of the lungs. Unlike traditional imaging methods, it can assess regional lung physiology and is particularly promising for managing lung diseases, including lung cancer.12345

Research Team

JC

Jason C Woods, Ph.D.

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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

I've had symptoms like a cough, chest tightness, or sinus infection in the last week.
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.
Standard MRI exclusions (metal, implants).
See 4 more

Timeline

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)

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Hyperpolarized 129 XenonExperimental Treatment2 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+

Findings from Research

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.
Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI.Song, EJ., Kelsey, CR., Driehuys, B., 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.
Repeatability of regional pulmonary functional metrics of Hyperpolarized 129 Xe dissolved-phase MRI.Hahn, AD., Kammerman, J., Evans, M., et al.[2020]
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.
The role of hyperpolarized 129xenon in MR imaging of pulmonary function.Ebner, L., Kammerman, J., Driehuys, B., et al.[2018]

References

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. [2022]
Repeatability of regional pulmonary functional metrics of Hyperpolarized 129 Xe dissolved-phase MRI. [2020]
The role of hyperpolarized 129xenon in MR imaging of pulmonary function. [2018]
Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. [2017]
Large production system for hyperpolarized 129Xe for human lung imaging studies. [2022]
Regulating MR Safety Standards. [2021]
Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. [2020]
The cumulative effects and clinical safety of repeat magnetic resonance imaging on an MRI-conditional pacemaker system at 1.5 tesla. [2022]
Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. [2013]
Safe performance of magnetic resonance of the heart in patients with magnetic resonance conditional pacemaker systems: the safety issue of the ESTIMATE study. [2021]