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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new type of lung scan, called HP 129Xe MRI, to help doctors identify and predict side effects from radiation therapy in lung cancer patients. Unlike traditional MRI scans, this one uses an inhaled tracer instead of an injection. The trial seeks healthy individuals who can hold their breath for 10-12 seconds and those with a confirmed lung cancer diagnosis undergoing radiation treatment. Participants must travel to the University of Texas MD Anderson Cancer Center for follow-ups. As an Early Phase 1 trial, this research aims to understand how this innovative scan functions in people, offering participants a chance to contribute to groundbreaking advancements in lung cancer care.

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 prior data suggests that this HP 129Xe MRI is safe for use in humans?

Research has shown that HP 129Xe MRI, which uses a special gas for imaging, has been used to study lung problems. In these studies, participants inhaled the gas, which helped reveal lung function. So far, this method appears safe, with no major issues reported.

As this study is in the early stages, researchers are primarily focused on assessing the treatment's safety. Although the 129Xe tracer lacks FDA approval, earlier studies suggest it does not cause serious side effects. Participants can feel reassured knowing that safety remains a top priority in these trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HP 129Xe MRI because it offers a new way to visualize lung function in patients with lung cancer. Unlike traditional imaging methods such as CT or PET scans, this technique uses hyperpolarized xenon gas, which patients inhale. This approach allows for a non-invasive, detailed look at how air moves through the lungs and how well gases are exchanged. It's especially promising because it could help doctors better understand and track lung health without exposing patients to radiation. This could lead to earlier detection of changes in lung function, potentially improving treatment planning and outcomes.

What evidence suggests that HP 129Xe MRI is effective for identifying and predicting side effects of radiation therapy?

Research has shown that HP 129Xe MRI is a promising method for assessing lung function. It allows doctors to evaluate how air moves and exchanges in the lungs. Studies have found that this technique can track changes in lung function after radiation therapy. This method is highly sensitive and can detect small changes in lung structure and function. In this trial, participants will be divided into different groups, including high-risk and low-risk RP patients, as well as healthy volunteers. Although still under investigation, HP 129Xe MRI might help identify and predict common side effects of radiation therapy in lung cancer patients. ^{4 6 7 8 9}

Who Is on the Research Team?

Joshua Niedzielski

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 (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 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 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]

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]

Citations

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

Hyperpolarized 129Xe MRI and Spectroscopy Xenon 129 MRI and MR spectroscopy are safe, sensitive, and robust tools for measuring pulmonary ventilation, gas exchange, and microstructure, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9776850/

Targeted Imaging of Lung Cancer with Hyperpolarized ... A previous study also reported that proton contrast-enhanced MRI was able to detect lung cancers 20 weeks after urethane administration [36].

3. redjournal.org redjournal.org/article/S0360-3016(24)00359-6/fulltext

Quantifying Regional Radiation-Induced Lung Injury in ... 129 Xe gas exchange technique to map lung function. Four patients underwent an additional 8-month post-RT MRI. The MR signal from inhaled xenon was measured.

4. 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 ...

5. advanced.onlinelibrary.wiley.com advanced.onlinelibrary.wiley.com/doi/10.1002/advs.202413426

Ultrasensitive 129Xe Magnetic Resonance Imaging: From ... It effectively tackles the challenge of weak MRI signals from low proton density in the lungs. HP 129Xe MRI is valuable for assessing structural ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9134268/

Lung Abnormalities Detected with Hyperpolarized 129Xe ... This pilot study used hyperpolarized (HP) xenon 129 (129Xe) MRI to evaluate the lungs of nonhospitalized participants with post-COVID-19 condition ...

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0720048X14002149

Review Pulmonary hyperpolarized noble gas MRI Using HP noble gases such as helium-3 (3He) and xenon-129 (129Xe), the MR signal in the airspaces of the lungs increases 100,000 times, supplying high- ...

9. 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 ...