HP 129Xe MRI for Lung Cancer

Overseen By Joshua Niedzielski, PHD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pulmonary disorders, Pregnant, Claustrophobia, others

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

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

Trial Summary

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's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment HP 129Xe MRI for lung cancer?

HP 129Xe MRI is a promising imaging method because it can assess lung ventilation and gas transfer, which are important for understanding lung function. Although most research has focused on non-cancer lung diseases, its ability to provide detailed images of lung structure and function suggests potential benefits for managing lung cancer. ^{1 2 3 4 5}

Is HP 129Xe MRI safe for humans?

HP 129Xe MRI has been used in clinical trials and research for lung imaging, showing promise as a safe method for evaluating lung function. It has been tested in both adults and children, including those with conditions like cystic fibrosis, without significant safety concerns reported. ^{1 4 5 6 7}

How does HP 129Xe MRI differ from other treatments for lung cancer?

HP 129Xe MRI is unique because it provides detailed images of lung ventilation and gas exchange, offering insights into lung function that traditional imaging methods cannot. This imaging technique is particularly novel for lung cancer management as it allows for the assessment of both ventilation and gas transfer, which are crucial for understanding lung physiology in cancer patients. ^{1 2 5 8 9}

What is the purpose of this trial?

The goal of this clinical research study is to learn if novel type of imaging scan called HP 129Xe MRI can help doctors identify and predict common side effects of radiation therapy. Rather than contrast-enhanced MRIs, the tracer (129Xe) will be inhaled rather than injected. The 129Xe tracer has not been FDA approved. Its use in this study is investigational.

Research Team

Joshua Niedzielski

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for lung cancer patients who are about to receive or are currently receiving radiation therapy. It aims to see if a new type of MRI scan can predict and identify side effects from the treatment.

Inclusion Criteria

Healthy control cohort: Able to consistently hold breath for 10-12 seconds

Lung cancer patient cohort: Able to understand and willing to sign a written informed consent document

I can have an MRI scan.

Exclusion Criteria

Pregnant women

Patients unable to follow up at MD Anderson for routine clinical care

Inability or unwillingness to give informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive radiation therapy while undergoing HP 129Xe MRI to assess imaging features and predict radiation pneumonitis

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after radiation therapy, with a focus on adverse events and radiation pneumonitis

1 year

Treatment Details

Interventions

• HP 129Xe MRI

Trial Overview The study is testing an investigational imaging technique called HP 129Xe MRI, where patients inhale a tracer gas (Xenon-129) instead of using traditional contrast agents, to monitor radiation response in lung tissue.

Participant Groups

Group I: Arm C: Healthy Volunteers (Negative Control) Experimental Treatment 1 Intervention

Group II: Arm B: Low-Risk RP Patients Experimental Treatment 1 Intervention

Group III: Arm A: High-Risk RP Patients Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

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.

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) 129 Xe MRI is a safe and rapid imaging technique that provides unique insights into lung function, including ventilation and gas exchange, which are not achievable with traditional imaging methods.

To enhance the consistency and reliability of HP 129 Xe MRI across different research sites, the 129 Xe MRI Clinical Trials Consortium has proposed standardized protocols for image acquisition and dosing, aiming to facilitate its broader use in clinical trials for pulmonary disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocols for multi-site trials using hyperpolarized 129 Xe MRI for imaging of ventilation, alveolar-airspace size, and gas exchange: A position paper from the 129 Xe MRI clinical trials consortium. Niedbalski, PJ., Hall, CS., Castro, M., et al.[2022]

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]

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 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 gases like (3)He and (129)Xe are emerging as noninvasive contrast agents for MRI, particularly useful in diagnosing pulmonary diseases.

Recent advancements in HP (129)Xe MR measurements have enhanced our ability to study lung dysfunctions in mice, paving the way for potential applications in human diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Small animal imaging with hyperpolarized 129Xe magnetic resonance. Imai, H., Kimura, A., Fujiwara, H.[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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Protocols for multi-site trials using hyperpolarized 129 Xe MRI for imaging of ventilation, alveolar-airspace size, and gas exchange: A position paper from the 129 Xe MRI clinical trials consortium. [2022]

3. Belgium pubmed.ncbi.nlm.nih.gov

Contribution of MRI in lung cancer staging. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. [2017]

5. Ireland pubmed.ncbi.nlm.nih.gov

The role of hyperpolarized 129xenon in MR imaging of pulmonary function. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Feasibility, tolerability and safety of pediatric hyperpolarized 129Xe magnetic resonance imaging in healthy volunteers and children with cystic fibrosis. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Small animal imaging with hyperpolarized 129Xe magnetic resonance. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Brain Imaging Using Hyperpolarized 129Xe Magnetic Resonance Imaging. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Acquiring Hyperpolarized 129Xe Magnetic Resonance Images of Lung Ventilation. [2023]